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Clizin
Meclizine Hydrochloride
Clizin
Meclizine Hydrochloride
Indications
Vertigo
Indication detailsView
Meclizine Hydrochloride is indicated in nausea, vomiting, motion sickness, vertigo.
Therapeutic classView
Anti-emetic drugs
PharmacologyView
Meclizine has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers. Meclizine has an onset of action of 30 to 60 minutes, depending on dosage; their duration of action is 12 to 24 hours.
DosageView
Adult & children over 12 years of age:
Use in elderly: There is no specific information available. However older people may be especially sensitive to the anticholinergic effects of medicine.
- Nausea and vomiting: 25-50 mg once daily.
- Motion sickness: Take an initial dose of 25 to 50 mg, 1 hour prior to travel. May repeat dose every 24 hours for the duration of the journey. Children: Age 6-12 years, 12.5 mg once daily. Age 2-6 years, 6.25 mg once daily.
- Vertigo: 25 to 100 mg daily in divided doses.
- Radiotherapy induced nausea and vomiting: 50 mg two to twelve hours prior to radiotherapy.
- Emergency contraception: 25-50 mg, 1 hour before first ECP dose; repeat if needed in 24 hours.
Use in elderly: There is no specific information available. However older people may be especially sensitive to the anticholinergic effects of medicine.
Side effectsView
Common side effects are Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.
ContraindicationsView
Meclizine is contraindicated in patients hypersensitive to Meclizine or any of its excipeints.
PrecautionsView
Patients with asthma, bronchitis, emphysema, enlarged prostate, glaucoma or urinary tract blockage should take Meclizine (like other antiemetics) with caution.
InteractionsView
Meclizine may increase the toxicity with CNS depressants, neuroleptics and anticholinergic. Alcohol, sedatives and tranquilizers can increase the drowsiness of the patient.
Pregnancy & lactationView
Meclizine shows no risk of birth defects or abnormalities when administered during pregnancy. Although Meclizine may excrete into the milk, it causes no harm in nursing babies.
Overdose effectsView
Symptoms: Extreme excitability, seizures, drowsiness and hallucinations.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis.
StorageView
Store in a cool & dry place and away from children.
Clob
Clobazam
Clob
Clobazam
Indications
Tension
Indication detailsView
Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
Therapeutic classView
Benzodiazepine hypnotics
PharmacologyView
Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
DosageView
General Dosage: Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
Treatment of anxiety states-
Adults and adolescents over 15 years of age: The initial dose is usually 20 mg clobazam daily. If necessary, the daily dose may be increased. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Treatment of epilepsy in combination with one or more other anticonvulsants-
Adults and adolescents over 15 years of age: It is recommended that administration be started at small doses (5 to 15 mg daily), if necessary, increasing the dose gradually to a maximum daily dose of about 80 mg.Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
AdministrationView
The tablets can be administered whole, or crushed and mixed in applesauce. The 10 mg tablets can be divided into equal halves of 5 mg. Clobazam can be given with or without food.
Side effectsView
Metabolism and nutrition disorders: Common: decreased appetite
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
ContraindicationsView
Clobazam must not be used-
- In patients with hypersensitivity to clobazam or any of the excipients of Clobazam.
- In patients with myasthenia gravis (risk of aggravation of muscle weakness).
- In patients with severe respiratory insufciency (risk of deterioration).
- In patients with sleep apnoea syndrome (risk of deterioration).
- In patients with severe impairment of liver function (risk of precipitating encephalopathy).
- In breast-feeding women Benzodiazepines must not be given to children without careful assessment of the need for their use.
- Clobazam must not be used in children between the ages of 6 months and 3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication.
PrecautionsView
Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
InteractionsView
Alcohol: Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% and therefore lead to increased clobazam effects.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Pregnancy & lactationView
Pregnancy: Clobazam is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception. Clobazam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have demonstrated reproductive toxicity. Clobazam crosses the placenta. In the post-marketing safety database, limited data on exposed pregnancies are available with clobazam. A large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines during the first trimester of pregnancy. However, in certain epidemiological case-control studies, an increased incidence of cleft lip and palate was observed with benzodiazepines. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy. Administration of clobazam during the late phase of pregnancy or during childbirth can result in the occurrence of neonatal respiratory depression (including respiratory distress and apnea), which may be associated with other disorders such as sedation signs, hypothermia, hypotonia, and feeding difficulties (which may result in poor weight gain) in the newborn (signs and symptoms of the so-called "floppy infant syndrome"). Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. Women of childbearing potential should be informed of the risks and benefits of the use of Clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, carefully evaluate the risks and benefits and whether treatment with Clobazam should be discontinued. If Clobazam treatment is to be continued, use Clobazam at the lowest effective dose.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
StorageView
Do not use the medicine later than the date of expiry. Store below 30° and protect from light. Keep out of the reach of children.
Clobac
Cefaclor Monohydrate
Clobac
Cefaclor Monohydrate
Indications
Urinary tract infection
Indication detailsView
Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.
DosageView
Adult-
- Usual dose: 250 mg 8 hrly.
- Bronchitis & pneumonia: 250 mg tid.
- Sinusitis: 500 mg tid for 10 days.
- Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
- Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.
- Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
- Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
- Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.
AdministrationView
May be taken with or without food.
Side effectsView
Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
ContraindicationsView
Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
PrecautionsView
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.
InteractionsView
The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.
Overdose effectsView
Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
StorageView
Store in a cool and dry place. Protect from light.
Clobac
Cefaclor Monohydrate
Clobac
Cefaclor Monohydrate
Indications
Urinary tract infection
Indication detailsView
Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.
DosageView
Adult-
- Usual dose: 250 mg 8 hrly.
- Bronchitis & pneumonia: 250 mg tid.
- Sinusitis: 500 mg tid for 10 days.
- Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
- Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.
- Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
- Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
- Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.
AdministrationView
May be taken with or without food.
Side effectsView
Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
ContraindicationsView
Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
PrecautionsView
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.
InteractionsView
The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.
Overdose effectsView
Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
StorageView
Store in a cool and dry place. Protect from light.
Clobecort
Clobetasone Butyrate
Clobecort
Clobetasone Butyrate
Indications
Seborrhoeic dermatitis
Indication detailsView
Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.
Therapeutic classView
Clobetasol / Clobetasone & Combined Preparations
PharmacologyView
Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.
DosageView
Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.
Side effectsView
Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning
ContraindicationsView
Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.
PrecautionsView
May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.
InteractionsView
Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.
Pregnancy & lactationView
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
Overdose effectsView
Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
StorageView
Store below 30˚ C. Do not freeze. Protect from light.
Clobecort
Clobetasone Butyrate
Clobecort
Clobetasone Butyrate
Indications
Seborrhoeic dermatitis
Indication detailsView
Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.
Therapeutic classView
Clobetasol / Clobetasone & Combined Preparations
PharmacologyView
Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.
DosageView
Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.
Side effectsView
Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning
ContraindicationsView
Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.
PrecautionsView
May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.
InteractionsView
Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.
Pregnancy & lactationView
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
Overdose effectsView
Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
StorageView
Store below 30˚ C. Do not freeze. Protect from light.
Clobederm
Clobetasol Propionate (Topical Preparation)
Clobederm
Clobetasol Propionate (Topical Preparation)
Indications
Vitiligo
Indication detailsView
Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Therapeutic classView
Other Topical corticosteroids
PharmacologyView
Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
DosageView
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
AdministrationView
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Side effectsView
The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
ContraindicationsView
It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
PrecautionsView
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
InteractionsView
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Pregnancy & lactationView
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Pediatric usageView
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
StorageView
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
Clobederm
Clobetasol Propionate (Topical Preparation)
Clobederm
Clobetasol Propionate (Topical Preparation)
Indications
Vitiligo
Indication detailsView
Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Therapeutic classView
Other Topical corticosteroids
PharmacologyView
Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
DosageView
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
AdministrationView
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Side effectsView
The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
ContraindicationsView
It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
PrecautionsView
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
InteractionsView
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Pregnancy & lactationView
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Pediatric usageView
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
StorageView
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
Clobenate
Clobetasol Propionate (Topical Preparation)
Clobenate
Clobetasol Propionate (Topical Preparation)
Indications
Vitiligo
Indication detailsView
Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Therapeutic classView
Other Topical corticosteroids
PharmacologyView
Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
DosageView
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
AdministrationView
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Side effectsView
The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
ContraindicationsView
It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
PrecautionsView
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
InteractionsView
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Pregnancy & lactationView
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Pediatric usageView
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
StorageView
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
Clobenate
Clobetasol Propionate (Topical Preparation)
Clobenate
Clobetasol Propionate (Topical Preparation)
Indications
Vitiligo
Indication detailsView
Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Therapeutic classView
Other Topical corticosteroids
PharmacologyView
Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
DosageView
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
AdministrationView
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Side effectsView
The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
ContraindicationsView
It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
PrecautionsView
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
InteractionsView
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Pregnancy & lactationView
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Pediatric usageView
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
StorageView
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
Clobeon
Clobetasol Propionate + Neomycin Sulphate + Nystatin
Clobeon
Clobetasol Propionate + Neomycin Sulphate + Nystatin
Indications
Severe inflammatory skin disorders
Indication detailsView
This preparation is indicated in-
- Short courses treatment of recalcitrant eczemas.
- Neurodermatoses.
- Psoriasis (excluding widespread plaque psoriasis) where secondary bacterial infection or fungal infection is present, suspected or likely to occur.
- Other inflammatory conditions which do not respond satisfactorily to less active steroids.
Therapeutic classView
Clobetasol / Clobetasone & Combined Preparations
PharmacologyView
Clobetasol Propionate is a very potent corticosteroid. It is prescribed to treat severe inflammatory skin disorders such as eczema and psoriasis that have not responded to weaker corticosteroids. Neomycin Sulphate is an antibiotic of the aminoglycoside type and is used to treat infections with bacteria. Nystatin is an antifungal that kills fungi and yeasts by interfering with their cell membranes. The mechanism of the topical steroids like Clobetasol, in general, is unclear. However, Clobetasol Propionate is highly active corticosteroid with topical anti-inflammatory activity. The major effect of Clobetasol Propionate on skin is a nonspecific anti-inflammatory response, partially due to vasoconstriction and decrease in collagen synthesis. Neomycin binds to the ribosomal 30s and 50s sub-units of susceptible bacteria and inhibits protein synthesis. Neomycin also causes a misreading of the genetic codes of the mRNA template and this causes incorrect amino acids to be incorporated into the growing polypeptide chain. Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components.
DosageView
Adults: Apply sparingly to the affected area once or twice daily until improvement occurs. In very resistant lesion, especially where there is hyperkeratosis, the anti-inflammatory effect of this preparation can be enhanced (if necessary) by occluding the treatment area with polythene. Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient's condition being reviewed.
Elderly: This preparation is suitable for use in elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.
Children: This preparation is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus this cream/ointment is not recommended for use in neonates and infants (younger than 2 years).
Elderly: This preparation is suitable for use in elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulphate may occur.
Children: This preparation is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus this cream/ointment is not recommended for use in neonates and infants (younger than 2 years).
Side effectsView
As with other topical corticosteroids, prolonged use of large amount or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. The effect is more likely to occur in infants and children and if occlusive dressings are used. Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved. There are reports of pigmentation changes and hypertrichosis with topical steroids.
ContraindicationsView
This medication is contraindicated in rosacea, acne vulgaris and perioral dermatitis, primary cutaneous viral infection (eg-Herpes simplex, chicken pox) and hypersensitivity to the preparation.
PrecautionsView
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. If this medication does enter the eye, the affected eye should be thoroughly washed with copious amount of water.
InteractionsView
Neomycin Sulphate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents following significant systemic absorption. However, if used in accordance with the recommendations, systemic exposure to Neomycin Sulphate is expected to be minimal and drug interactions are unlikely to be significant. No hazardous interactions have been reported with use of Clobetasol Propionate or Nystatin.
Pregnancy & lactationView
There is little information to demonstrate the possible effect of topically applied Neomycin in pregnancy and lactation. However, Neomycin present in the maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus the use of the preparation is not recommended in pregnancy and lactation. The safety of Clobetasol Propionate has not been established in lactating mothers.
Overdose effectsView
Acute overdosage is very unlikely to occur. No overdose-related problem yet reported. However, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation, topical steroids should be discontinued gradually.
StorageView
Store below 25°C temperature. Do not freeze. Keep out of reach of children.
Clobesol
Clobetasol Propionate (Topical Preparation)
Clobesol
Clobetasol Propionate (Topical Preparation)
Indications
Vitiligo
Indication detailsView
Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Therapeutic classView
Other Topical corticosteroids
PharmacologyView
Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
DosageView
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
AdministrationView
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Side effectsView
The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
ContraindicationsView
It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
PrecautionsView
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
InteractionsView
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Pregnancy & lactationView
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Pediatric usageView
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
StorageView
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
Clobesol
Clobetasol Propionate (Topical Preparation)
Clobesol
Clobetasol Propionate (Topical Preparation)
Indications
Vitiligo
Indication detailsView
Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less potent steroids
Therapeutic classView
Other Topical corticosteroids
PharmacologyView
Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.
DosageView
Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.
AdministrationView
Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.
Side effectsView
The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.
ContraindicationsView
It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.
PrecautionsView
In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.
InteractionsView
Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.
Pregnancy & lactationView
There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.
Pediatric usageView
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.
StorageView
Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.
Clobesol SA
Clobetasol Propionate + Salicylic Acid
Clobesol SA
Clobetasol Propionate + Salicylic Acid
Indications
Warts
Indication detailsView
This ointment is indicated for the relief of the inflammatory manifestations of hyperkeratotic and dry corticosteroid responsive dermatoses such as, psoriasis, chronic atopic dermatitis, neurodermatitis (licehen Simplex, Chronicus), lichen planus, eczema (including nummular eczema, hand eczema, eczematous dermatitis), seborrheic dermatitis of the scalp, ichthyosis vulgaris and other ichthyotic conditions.
Therapeutic classView
Clobetasol / Clobetasone & Combined Preparations
PharmacologyView
Clobetasol Propionate high potency corticosteroid. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; and reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation.
Salicylic acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.
Salicylic acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.
DosageView
Adult: Apply a thin layer of this ointment to the affected skin areas twice daily and rub in gently & completely. For some patients, adequate maintenance therapy may be achieved with less frequent application. As with other higher active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. It should not be used with occlusive dressing. Treatment beyond 2 consecutive weeks is not exceeding 50 gm/week because of the potential for the drug to suppress the hypothalamic pituitary adrenal axis.
Children: Use in pediatric patients under 12 years of age is not recommended.
Children: Use in pediatric patients under 12 years of age is not recommended.
AdministrationView
For external use only.
Side effectsView
As with other topical corticosteroids, prolonged use of large amounts of Clobetasol Propionate or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment. In rare instances, treatment of psoriasis with corticosteroids (or its withdrawal) is thought to have provoked the pustular form of the diseases. Clobetasol Propionate is usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. Possible sensitivity reactions, drying and irritation when using Salicylic Acid.
ContraindicationsView
ClobetasolPropionatev is contraindicated in patients with hypersensitivity to Clobetasol Propionate. This preparation is contraindicated also in the treatment of primary infected bacterial or fungal skin lesions if no anti-infective agent is used simultaneously, in primary cutaneous viral infections (i.e., herpes simplex, vaccinia and varicella) and in tuberculous skin lesions. Clobetasol Propionate is also contraindicated in dermatoses in children under one year of age, including dermatitis and diaper eruptions. Salicylic Acid is contraindicated in patients displaying salicylate hyersensitivity, or sensitivity to any other ingredient in the preparation.
PrecautionsView
Not for prolonged use in high concentrations and on large areas of the body. Impaired peripheral circulation or diabetes. Avoid broken skin, mouth, eyes, mucous membranes and anogenital region.
InteractionsView
There has been no report of interaction with Clobetasol Propionate ointment and cream. There are no known interactions of Salicylic Acid when used as indicated. However, topical salicylic acid may increase the absorption of other topically applied medicines. Concomitant use of Salicylic Acid Ointment and other topical medicines on the same area of skin should therefore be avoided.
Pregnancy & lactationView
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. The relevance of this finding to human beings has not been established. The safe use of Clobetasol Propionate during lactation has not been established. However, the administration of Clobetasol Propionate during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Drugs of this class should not be used extensively in pregnant patients in large amounts or for prolonged periods of time. Whilst there are no known contra-indications to the use of Salicylic Acid ointment during pregnancy and lactation, the safety has not been established. Salicylic Acid ointment shold therefore be used with caution.
Overdose effectsView
Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may appear and in this situation topical steroids should be discontinued gradually. However, because of the risk of acute adrenal suppression this should be done under medical supervision. Symptoms osslystemic salicylate poisoning (tinnitus, dizziness and deafness) have been reported after the application of Salicylic Acid to large areas of skin and for prolonged periods. Salicylism may also occur in the unlikely event of large quantities being ingested. Salicylism is ullikely to occur if Salicylic Acid ointment is used as indicated. Salicylate poisoining is usually associated with plasma concentrations >350 mg/L. Most adult deaths occur in patients whose concentrations exceed 700 ml/L. Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
StorageView
Store in a cool and dry place, protected from light.
Clobex
Cloxacillin Sodium
Clobex
Cloxacillin Sodium
Indications
UTI caused by Staphylococcus Aureus
Indication detailsView
গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
Therapeutic classView
Penicillinase-resistant penicillins
DosageView
প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
- শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
- প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
- জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
- শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
- প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
- জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
Side effectsView
ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।
ContraindicationsView
পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।
PrecautionsView
যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
StorageView
ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।
Clobex
Cloxacillin Sodium
Clobex
Cloxacillin Sodium
Indications
UTI caused by Staphylococcus Aureus
Indication detailsView
গ্রাম-পজিটিভ জীবাণু দ্বারা সৃষ্ট সংক্রমণের চিকিৎসায় ক্লক্সাসিলিন নির্দেশিত। পেনিসিলিনেজ উৎপাদনক্ষম স্টেফাইলোকক্কাই জনিত সংক্রমণের চিকিৎসায়ও এটি নির্দেশিত। এ জাতীয় সংক্রমণের মধ্যে রয়েছেঃ
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
স্কিন ও সফ্ট টিস্যু সংক্রমণ: ফোঁড়া (boils), পূজাশয় (abscess), কার্বাংকল, ফারানকুলোসিস, সেলুলাইটিস, সংক্রমিত ক্ষত (infected wounds), সংক্রমিত পোড়া (infected burns), ত্বক প্রতিস্থাপন প্রতিরক্ষা (protection for skin grafts), ত্বকের বিভিন্ন সংক্রমণ যেমন আলসার, একজিমা ও একনি।
রেসপিরেটরী ট্র্যাক্ট, নাক, কান ও গলার সংক্রমণ: নিউমোনিয়া, ফুসফুসের পূজাশয় (lung abscess), এমপায়েমা, সাইনোসাইটিস, ফ্যারিনজাইটিস, টনসিলাইটিস, কুইনসি, অটাইটিস মিডিয়া ও এক্সটারণা।
ক্লক্সাসিলিন-সংবেদনশীল (sensitive), জীবাণু জনিত অন্যান্য সংক্রমণ: অসটিওমায়েলাইটিস, এনটেরাইটিস, এনডোকারডাইটিস, ইউরিনারী ট্র্যাক্ট সংক্রমণ ও সেপটিসেমিয়া।
Therapeutic classView
Penicillinase-resistant penicillins
DosageView
প্রাপ্তবয়স্কদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
খাওয়ার জন্য: ৫০০ মিগ্রা দিনে চার বার আহারের আধা থেকে এক ঘন্টা আগে।
ইনজেকশন হিসেবে:
- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর।
- শিরাপথে ইনজেকশন হিসেবে: ৫০০ মিগ্রা চার থেকে ছয় ঘন্টা পর পর। প্রয়োজনবোধে উপরোল্লিখিত মাত্রাকে দ্বিগুণ করা যেতে পারে।
- প্লুরাল কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
- জয়েন্ট কেভিটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা দিনে এক বার।
শিশুদের প্রচলিত মাত্রা-
খাওয়ার জন্য: ২ থেকে ১০ বৎসর পর্যন্ত- প্রাপ্তবয়স্ক মাত্রার অর্ধেক। ২ বৎসরের নীচে- প্রাপ্তবয়স্ক মাত্রার এক-চতুর্থাংশ।
ইনজেকশন হিসেবে:
- মাংসপেশীতে ইনজেকশন হিসেবে: ২৫০ মিগ্রা এর সাথে ১.৫ মিলি কিংবা ৫০০ মিগ্রা এর সাথে ২ মিলি ওয়াটার ফর ইনজেকশন বিপি মিশিয়ে দ্রবীভূত করতে হবে।
- শিরাপথে ইনজকেশন হিসাবে: ৫০০ মিগ্রা এর সাথে ৫-১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করতে হবে। এরপর এই দ্রবণকে তিন থেকে চার মিনিট ধরে ধীরে ধীরে শরীরে প্রয়োগ করতে হবে। ক্লক্সাসিলিন ইনজকেশনকে ইনফিউশন উপযোগী যে কোন তরলে মিশিয়ে দেয়া যায় অথবা যথাযথ ভাবে হালকা করে ড্রপি টউিবে তিন থেকে চার মিনিট ধরে ধীরে ধীরে প্রয়োগ করা যায়।
- প্লুরাল কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে ৫ থেকে ১০ মিলি ওয়াটার ফর ইনজকেশন বিপি মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
- জয়েন্টে কেভেটিতে ইনজেকশন হিসেবে: ৫০০ মিগ্রা এর সাথে অনধকি ৫ মিলি ওয়াটার ফর ইনজকেশন বিপি অথবা ০.৫% লিগনোকেইন হাইড্রোক্লোরাইড দ্রবণ মিশিয়ে দ্রবীভূত করে প্রয়োগ করতে হবে।
Side effectsView
ক্লক্সাসিলিন এর পার্শ্ব-প্রতিক্রিয়া অন্যান্য পেনিসিলিনের মতই। এগুলো সাধারণতঃ মৃদু ও ক্ষণস্থায়ী হয়ে থাকে। এই সমস্ত পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে জ্বর, ডায়রিয়া, অজীর্ণ (indigestion), র্যাশ-আরটিকারিয়েল অথবা ইরিথিমেটাস জাতীয়। যে কোন ধরণের র্যাশে রোগীকে এ ওষুধ দেয়া বন্ধ করতে হবে।
ContraindicationsView
পেনিসিলিনে অতি-সংবেদনশীল (hypersensitive) রোগীদের ক্ষেত্রে ক্লক্সাসিলিন প্রয়োগ নিষিদ্ধ।
PrecautionsView
যে সব রোগীর এলার্জির পূর্ব ইতিহাস আছে তাদের বেলায় ক্লক্সাসিলিন সতর্কতার সাথে ব্যবহার করতে হবে। ক্লক্সাসিলিন সাব-কনজাংটিভাল ইনজেকশন হিসেবে অথবা চোখের ড্রপস হিসেবে দেয়া যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
ক্লক্সাসিলিন সিরাপ ও ড্রপস ব্যবহরের আগে তাৎক্ষনিকভাবে তৈরী করে ঠাণ্ডা স্থানে (সম্ভব হলে রেফ্রিজারেটরে) রাখতে হবে। সংমিশ্রিত সিরাপ ও ড্রপস সাধারণ তাপমাত্রায় রাখলে পাঁচ দিনের মধ্যে অথবা রেফ্রিজারেটরে রাখলে সাত দিনের মধ্যে ব্যবহার করতে হবে। মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য প্রস্তুতকৃত ক্লক্সাসিলিন দ্রবণ তৈরীর ৩০ মিনিটের মধ্যে ব্যবহার করতে হবে। অবশ্য ক্লক্সাসিলিন এর জলীয় দ্রবণ স্বাভাবিক তাপমাত্রায় (২৫° সেঃ) অনধিক ২৪ ঘন্টা পর্যন্ত কার্যকর থাকে।
শিরাপথের প্রয়োগোপযোগী অধিকাংশ তরলের সাথেই ক্লক্সাসিলিন মেশানো যায়। তবে কখনোই আমিষ জাতীয় তরল (যেমন প্রোটিন হাইড্রোলাইসেটস) এর সাথে মেশানো যাবে না।
StorageView
ক্লক্সাসিলিন এর সকল ডোসেজ ফরমকে ঠান্ডা ও শুকনো স্থানে রাখতে হবে। ক্লক্সাসিলিন ইনজেকশন ভায়ালকে অনধিক ২৫° সেঃ তাপমাত্রায় সংরক্ষণ করুন।
Clobid
Clobazam
Clobid
Clobazam
Indications
Tension
Indication detailsView
Acute and chronic anxiety states which may produce the following symptoms in particular: anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
In patients with depression or anxiety associated with depression, Clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines alone, can precipitate suicide in such patients. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
Therapeutic classView
Benzodiazepine hypnotics
PharmacologyView
Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
DosageView
General Dosage: Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
Treatment of anxiety states-
Adults and adolescents over 15 years of age: The initial dose is usually 20 mg clobazam daily. If necessary, the daily dose may be increased. Generally, it is recommended that a total daily dose of 30 mg is not exceeded.Elderly: Increased responsiveness and higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation. A maintenance dose of 10 to 15 mg clobazam daily is frequently sufficient.
Children from 3 to 15 years of age: Increased responsiveness and higher susceptibility to adverse effects may be present in children and require low initial doses and gradual dose increments under careful observation. A daily dose of 5 to 10 mg clobazam is frequently sufficient. Benzodiazepines must not be given to children without careful assessment of the need for their use.
Secondary dosage adjustment: After the improvement of the symptoms, the dose may be reduced.
Timing of doses: If the dose is to be spread throughout the day, it is recommended that the larger portion be taken in the evening.
Duration of treatment: The duration of treatment must be as short as possible. The patient must be reassessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment, especially where the patient is free of symptoms. Generally, the overall duration of treatment (i.e. including tapering-of process) must not exceed 8 to 12 weeks. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without a re-evaluation of the patient's status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence.
Discontinuation of treatment: It is strongly recommended that after prolonged treatment clobazam is not withdrawn suddenly but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.
Treatment of epilepsy in combination with one or more other anticonvulsants-
Adults and adolescents over 15 years of age: It is recommended that administration be started at small doses (5 to 15 mg daily), if necessary, increasing the dose gradually to a maximum daily dose of about 80 mg.Children from 3 to 15 years of age: It is recommended that normally treatment be started at 5 mg daily. A maintenance dose of 0.3 to 1.0 mg/kg body weight daily is usually sufficient. Higher susceptibility to adverse effects may be present in children and require gradual dose increments under careful observation; Benzodiazepines must not be given to children without careful assessment of the need for their use.
Elderly: Higher susceptibility to adverse effects may be present in elderly patients and require low initial doses and gradual dose increments under careful observation.
Timing of doses: If the dose is spread throughout the day, it is recommended that the larger portion be taken in the evening. Doses of up to 30 mg clobazam can also be administered as a single evening dose.
Duration of treatment: The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment.
Discontinuation of treatment: At the end of treatment- to include cases in which response to therapy has been poor- it is strongly recommended that clobazam is not withdrawn suddenly but rather that the dose is reduced gradually; otherwise an increased susceptibility to seizures as well as other withdrawal symptoms may occur.
AdministrationView
The tablets can be administered whole, or crushed and mixed in applesauce. The 10 mg tablets can be divided into equal halves of 5 mg. Clobazam can be given with or without food.
Side effectsView
Metabolism and nutrition disorders: Common: decreased appetite
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
Psychiatric disorders: Common: irritability, aggression, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), agitation.
Nervous system disorders: Very common: somnolence, especially at the beginning of treatment and when higher doses are used; Common: sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder (particularly with high doses or in long-term treatment, and are reversible), headache, tremor, ataxia.
Eye Disorders: Uncommon: diplopia (particularly with high doses or in long-term treatment and is reversible)
Respiratory, thoracic and mediastinal disorders: Not known: respiratory depression respiratory failure (particularly in patients with pre-existing compromised respiratory function e.g. in patients with bronchial asthma or brain damage)
Gastrointestinal disorders: Common: dry mouth, nausea, constipation
Skin and subcutaneous disorders: Uncommon: rash; Not known: photosensitivity reaction urticaria; Steven Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome);
Musculoskeleteal and connective tissue disorders: Not known: muscle spasms, muscle weakness
General disorders and administration site conditions: Very common: fatigue, especially at the beginning of treatment and when higher doses are used. Not known: slow response to stimuli, hypothermia
Investigations: Uncommon: weight increased (particularly with high doses or in long-term treatment).
ContraindicationsView
Clobazam must not be used-
- In patients with hypersensitivity to clobazam or any of the excipients of Clobazam.
- In patients with myasthenia gravis (risk of aggravation of muscle weakness).
- In patients with severe respiratory insufciency (risk of deterioration).
- In patients with sleep apnoea syndrome (risk of deterioration).
- In patients with severe impairment of liver function (risk of precipitating encephalopathy).
- In breast-feeding women Benzodiazepines must not be given to children without careful assessment of the need for their use.
- Clobazam must not be used in children between the ages of 6 months and 3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication.
PrecautionsView
Serious Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the post-marketing experience. A majority of the reported cases involved the concomitant use of other drugs, including antiepileptic drugs that are associated with serious skin reactions. SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
Respiratory depression: Clobazam can cause respiratory depression, especially if administered in high doses. Therefore in patients with chronic or acute respiratory insufficiency, respiratory function must be monitored and a dose reduction may be necessary. Clobazam is contraindicated in patients with severe respiratory insufficiency.
Muscle weakness: Clobazam can cause muscle weakness. Clobazam is contraindicated in patients with myasthenia gravis.
Renal and hepatic impairment: In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.
Elderly patients: In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness, muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.
Tolerance in epilepsy: In the treatment of epilepsy with benzodiazepines- including Clobazam, consideration must be given to the possibility of a decrease in anticonvulsant efficacy (development of tolerance) in the course of treatment.
CYP2C19 poor metabolizers: In patients who are CYP2C19 poor metabolizers, levels of the active metabolite N-desmethylclobazam are expected to be increased as compared to extensive metabolizers. Dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).
Suicidality: Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with other benzodiazepines and hypnotics. There are very limited data available for clobazam in these studies. Cases of suicidal behavior have been reported with clobazam in post-marketing surveillance. All of these cases had confounding factors.
Concomitant use of CYP2C19 inhibitors: The concomitant use of clobazam with CYP2C19 inhibitors, including cannabidiol containing medicinal products, dietary supplements and recreational products may result in increased exposure to N-desmethylclobazam (NCLB). Such increases might lead to increased adverse effects, such as somnolence and sedation. When used with medicinal products that are CYP2C19 inhibitors dosage adjustment of clobazam may be necessary. Dietary supplements and recreational products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality
InteractionsView
Alcohol: Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% and therefore lead to increased clobazam effects.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Central nervous system depressant drugs: Especially when clobazam is administered in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant drugs, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
Opioids: The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids.
Anticonvulsants: If clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication. In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration. Phenytoin plasma levels may rise if patients receive concomitant treatment with clobazam. Where possible, it is recommended that blood levels of concomitantly administered valproic acid or phenytoin be monitored. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to the active metabolite N-desmethyl clobazam. Stiripentol increases plasma levels of clobazam and its active metabolite N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol, and then once new steady-state concentration has been reached, i.e. after 2 weeks approximately.
Narcotic analgesics: If clobazam is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.
Muscle relaxants: The effects of muscle relaxants and nitrous oxide may be enhanced.
CYP 2C19 inhibitors: Strong and moderate inhibitors of CYP2C19 may result in increased exposure to N-desmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of clobazam may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., cannabidiol containing medicinal products, fuconazole, fuvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g. omeprazole).
CYP 2D6 substrates: Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.
Pregnancy & lactationView
Pregnancy: Clobazam is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception. Clobazam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have demonstrated reproductive toxicity. Clobazam crosses the placenta. In the post-marketing safety database, limited data on exposed pregnancies are available with clobazam. A large amount of data collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines during the first trimester of pregnancy. However, in certain epidemiological case-control studies, an increased incidence of cleft lip and palate was observed with benzodiazepines. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines during the second and/or third trimester of pregnancy. Administration of clobazam during the late phase of pregnancy or during childbirth can result in the occurrence of neonatal respiratory depression (including respiratory distress and apnea), which may be associated with other disorders such as sedation signs, hypothermia, hypotonia, and feeding difficulties (which may result in poor weight gain) in the newborn (signs and symptoms of the so-called "floppy infant syndrome"). Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. Women of childbearing potential should be informed of the risks and benefits of the use of Clobazam during pregnancy. If a woman plans a pregnancy or becomes pregnant, carefully evaluate the risks and benefits and whether treatment with Clobazam should be discontinued. If Clobazam treatment is to be continued, use Clobazam at the lowest effective dose.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
Lactation: Clobazam must not be used in breastfeeding women, since clobazam passes into breast milk.
StorageView
Do not use the medicine later than the date of expiry. Store below 30° and protect from light. Keep out of the reach of children.
Clocard
Clopidogrel Bisulphate
Clocard
Clopidogrel Bisulphate
Indications
Unstable angina
Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)]. It is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI).
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke it is indicated to reduce the rate of MI and stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
DosageView
Acute Coronary Syndrome: In patients who need an antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4 tablets) oral loading dose and then continue at 75 mg once daily. Initiating it without a loading dose will delay establishment of an antiplatelet effect by several days.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Recent MI, Recent Stroke, or Established Peripheral Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
Side effectsView
Clopidogrel is generally well tolerated drug.
- Common side effects: Bleeding, Diarrhoea, gastrointestinal discomfort, haemorrhage, Skin reactions.
- Rare side effects: Acquired haemophilia, anaemia, angioedema, arthralgia, arthritis, bone marrow disorders.
ContraindicationsView
Clopidogrel is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
- As it is a prodrug, so metabolism to its active metabolite is impaired by genetic variations in CYP2C19 (poor metabolizer) and by the drugs that inhibit CYP2C19 such as Omeprazole and Esomeprazole. Concomitant use with these drugs and in CYP2C19 poor metaboliser may reduce the antiplatelet activity of Clopidogrel.
- As it inhibits platelet aggregation for the lifetime of the platelet (7-10 days), risk of bleeding may increase. To restore hemostasis, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.
- Discontinuation of Clopidogrel increases the risk of cardiovascular events. Discontinue 5 days prior to elective surgery that has a major risk of bleeding. Resume Clopidogrel as soon as hemostasis is achieved.
- Thrombotic Thrombocytopenic Purpura (TTP) has been reported that requires urgent treatment including plasmapheresis (plasma exchange).
- Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving clopidogrel or history of hypersensitivity to other thienopyridines.
InteractionsView
- NSAIDs, warfarin, selective serotonin and serotonin norepinephrine reuptake inhibitors (SSRIs, SNRIs): Increases risk of bleeding
- CYP2C19 inhibitors (omeprazole or esomeprazole): Avoid concomitant use of omeprazole or esomeprazole
- Repaglinide (CYP2C8 substrates): Avoid concomitant use of Clopidogrel with Repaglinide as it increases plasma concentrations of Repaglinide
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed. It is unknown whether clopidogrel is excreted in human breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric usageView
Safety and effectiveness in pediatric populations have not been established. No dosage adjustment is necessary in elderly patients.
Overdose effectsView
Overdose following clopidogrel administration may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability.
StorageView
Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.
Clocard-A
Clopidogrel + Aspirin
Clocard-A
Clopidogrel + Aspirin
Indications
Transient ischemic attack
Indication detailsView
Acute Coronary Syndrome (ACS): It is indicated to reduce the rate of Myocardial Infarction (MI) and Stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation Myocardial Infarction (NSTEMI)] and acute ST-segment elevation ACS [ST-elevation Myocardial Infarction (STEMI)].
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.
Recent MI, recent Stroke, or established Peripheral Arterial Disease: In patients with established peripheral arterial disease or with a history of recent Myocardial Infarction (MI) or recent Stroke it is indicated to reduce the rate of MI and Stroke.
Therapeutic classView
Anti-platelet drugs
PharmacologyView
Clopidogrel is a prodrug. It inhibits platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets. Dose-dependent inhibition of platelet aggregation can be seen at 2 hours after single oral doses. Repeated doses of 75 mg per day inhibit ADP-induced platelet aggregation on the first day, and inhibition reaches steady state between Day 3 and Day 7.
Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
Aspirin inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibiting the generation of thromboxane A2 a powerful inducer of platelet aggregation and vasoconstriction.
DosageView
The recommended oral dose is one tablet daily.
Side effectsView
This combination is generally well tolerated.
ContraindicationsView
This combination is contraindicated in the following conditions: Hypersensitivity to the drug substance or any component of the product. Active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
PrecautionsView
- This combination may prolongs the bleeding time.
- Thrombotic thrombocytopenic purpura (TTP): TTP has been reported rarely following use of this combination.
- Reye's syndrome: Reye's syndrome may develop in individuals who have chicken pox, influenza or flu symptoms. Hypersensitivity including rash, angioedema or hematologic reaction has been reported in patients receiving this combination or history of hypersensitivity to other thienopyridines
InteractionsView
Oral anticoagulants, NSAIDs, Metamizole, SSRIs, CYP2C19 inhibitors increase the risk of bleeding. It shows interaction with Tonofovir, Valproic acid, Varicella vaccine, Acetazolamide and Nicorandil.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. It should be used during first and second trimesters of pregnancy only if clearly needed. It is contraindicated during the third trimester of pregnancy. It is unknown whether Clopidogrel is excreted in human breast milk but Aspirin is known to be excreted in human milk. This Drug should be discontinued during the breast feeding.
Pediatric usageView
It should not be given to children, particularly those under 12 years, unless the expected benefits outweight the possible risks. Aspirin may be a contributory factor in the causation of Reye’s syndrome in some children.
Overdose effectsView
Clopidogrel overdose may lead to bleeding complications. Based on biological plausibility, platelet transfusion may restore clotting ability. In moderate aspirin intoxication dizziness, headache, tinnitus, confusion, and gastrointestinal symptoms may occur which can be treated by inducing vomiting followed by gastric lavage if needed. In severe Aspirin intoxication respiratory alkalosis respiratory acidosis, metabolic acidosis, hyperthermia, perspiration, dehydration can occur. It can be treated with haemodialysis and other symptomatic treatment.
StorageView
Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.
Clocef
Cefaclor Monohydrate
Clocef
Cefaclor Monohydrate
Indications
Urinary tract infection
Indication detailsView
Cefaclor is indicated in the treatment of the following infections: Otitis media, Lower respiratory tract infections, including pneumonia, bronchitis and acute exacerbation of chronic bronchitis, Upper respiratory tract infections, including pharyngitis and tonsillitis, Urinary tract infections, including pyelonephritis and cystitis, Skin and soft tissue infections, Sinusitis
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefaclor is a second generation cephalosporin antibiotic which has stability against b-lactamase inactivation and possesses a broad spectrum of activity. Cefaclor is active against the following organisms in vitro: Alpha and beta haemolytic Streptococci, Staphylococci; including coagulase-positive, coagulase negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes (Group A b-haemolytic Streptococci), Branhamella catarrhalis, Escherichia coli, Proteus mirabilis, Klebsiella species Haemophilus influenzae, including ampicillin-resistant strains. Cefaclor is generally effective in the eradication of Streptococci from the nasopharynx.
DosageView
Adult-
- Usual dose: 250 mg 8 hrly.
- Bronchitis & pneumonia: 250 mg tid.
- Sinusitis: 500 mg tid for 10 days.
- Pneumonia & other more severe infections: Max: 4 gm/day for 28 days.
- Acute gonococcal urethritis: 3 gm as a single dose combined with probenecid 1 gm.
- Recommended dose: 20 mg/kg/day in divided doses 8 hrly.
- Bronchitis & pneumonia: 20 mg/kg/day in divided doses tid.
- Serious infections, sinusitis, otitis media & infections: caused by less susceptible organisms 40 mg/kg/day in divided doses. Max: 1 gm/day.
AdministrationView
May be taken with or without food.
Side effectsView
Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
ContraindicationsView
Cefaclor is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
PrecautionsView
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Dosage adjustments for patients with moderate or severe renal impairment are not usually required.
InteractionsView
The nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramicin may be enhanced by any cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Small amounts of Cefaclor have been detected in mother's milk. The effect on nursing infants is not known. Caution should be exercised when Cefaclor is administered to a nursing woman.
Overdose effectsView
Symptoms: Nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.
StorageView
Store in a cool and dry place. Protect from light.