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Benzodiazepine hypnotics

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.

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.

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.

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.

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).

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.

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

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.

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.

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.

Albendazole is indicated in single and mixed infestations of-

• Hookworm (Ancylostoma, Necator)
• Roundworm (Ascaris)
• Threadworm (Enterobius)
• Whipworm (Trichuris)
• Strongyloides
• Tapeworm
• Opisthorchi
• Hydatid.

Anthelmintic

Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.

Adults & children over 2 years:

• 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
• In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated. 

Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

Children under 1 year: Not recommended.

In Hydatid disease (Echinococcosis):

• Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
• A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
• For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
• For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
• In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.

Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.

Neonates: Albendazole is not normally used in neonates.

Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.

Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.

Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.

Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts

No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.

US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Albendazole is indicated in single and mixed infestations of-

• Hookworm (Ancylostoma, Necator)
• Roundworm (Ascaris)
• Threadworm (Enterobius)
• Whipworm (Trichuris)
• Strongyloides
• Tapeworm
• Opisthorchi
• Hydatid.

Anthelmintic

Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.

Adults & children over 2 years:

• 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
• In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated. 

Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

Children under 1 year: Not recommended.

In Hydatid disease (Echinococcosis):

• Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
• A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
• For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
• For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
• In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.

Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.

Neonates: Albendazole is not normally used in neonates.

Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.

Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.

Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.

Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts

No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.

US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Bromhexine is indicated in the treatment of respiratory tract disorders associated with productive cough. This include-

• Tracheobronchitis
• Bronchitis with emphysema
• Bronchiectasis
• Bronchitis with bronchospasm
• Chronic inflammatory pulmonary conditions and
• Pneumoconiosis.

Cough expectorants & mucolytics

Bromhexine Hydrochloride is an oral mucolytic agent. It disrupts the structure of acid mucopolysaccharide fibres in mucoid sputum and produces less viscous mucus, which makes easier the expectoration. It is rapidly & completely absorbed from the gastrointestinal tract. It is widely distributed into the body tissues.

The recommended doses for adults and children are stated below:

• Adult & Children over 12 years: 10 ml (2 teaspoons) 3 times daily
• Children 6-12 years: 5 ml (1 teaspoon) 3 times daily
• Children 2-6 years: 2.5 ml (1/2 teaspoon) 3 times daily
• Bromhexine Hydrochloride is not recommended for children under 2 years of age without advice.

Gastrointestinal side effects may occur occasionally. A transient rise in serum aminotransferase values has been reported. Other reported side effects include-headache, vertigo (dizziness) and allergic reactions.

It is contraindicated in known hypersensitivity to Bromhexine Hydrochloride or any of the ingredients of this product.

Since mucolytics may disrupt the gastric mucosa bromhexine should be used with care in patients with a history of peptic ulcer disease. Care is also advisable in asthmatic patients. Clearance of bromhexine and its metabolites may be reduced in patients with severe hepatic or renal impairment.

There are no known significant interactions with other drugs.

Use in Pregnancy: Special care is recommended during pregnancy. The benefits of bromhexine must be assessed against possible effects on children.

Use in Lactation: Bromhexine is expected to enter breast milk. Therefore it is not recommended that bromhexine be taken by lactating mothers.

Keep in a dry place away from light and heat. Keep out of reach of children.

This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.

Combined cough expectorants

Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.

Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.

Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering this preparation to children aged less than 2 years.

CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.

This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.

As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.

Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.

The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.

Store below 25° C. Protect from light. Do not refrigerate.

Dextromethorphan is indicated in Chronic dry cough or unproductive cough; Acute dry cough which is interfering with normal function or sleep.

Cough suppressant

Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Adults and Children over 12 years: 15 to 30 mg three to four times per day. However, 60 mg doses up to four times per day have been used without increased side effects.
Children between 6 and 12 years: 5-15 mg up to four times per day.
Children between 2 and 6 years: 2.5-5 mg up to four times per day.

Adverse effects with Dextromethorphan are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression may occur after overdosage.

Hypersensitivity to Dextromethorphan or any other component.

Do not use Dextromethorphan to control a cough that is associated with smoking, asthma, or emphysema, or a cough that is productive (produces sputum or phlegm).

The following medicines should be taken carefully while concomitantly use with Dextromethorphan: Amiodarone, Fluoexetine, Quinidine, CNS depressants and Monoamine oxidase (MAO) inhibitors.

Pregnancy: Adequate and well-controlled studies in human have not been done. However, Dextromethorphan has not been reported to cause birth defects.

Lactation: It is not known whether dextromethorphan passes into breast milk. However, Dextromethorphan has not been reported to cause problems in nursing babies.

Symptoms: In mild overdose, tachycardia, hypertension, vomiting, mydriasis, diaphoresis, nystagmus, euphoria, loss of motor coordination, and giggling; in moderate intoxication, in addition to those listed above, hallucinations and a plodding ataxic gait; in severely intoxication, agitation or somnolence.

Management: treatment is symptomatic and supportive. Naloxone may be useful in reversing toxicity.

Store at 15-30° C

Dicycloverine is indicated in:

• Functional bowel/irritable bowel syndrome
• Urinary incontinence secondary to unstable detrusor muscle
• Infantile colic
• GIT spasm
• Colicky abdominal pain
• Diverticulitis
• Abdominal colic

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (Not For Intravenous Use). It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.

For oral dosage forms:

• Adults:10 to 20 mg three times a day.
• Children over 6 months of age: 5 to 10 mg three times a day.

For injectable dosage form:

• Adults: Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

Children: Dose must be determined by the doctor.

Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.

Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.

Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Dicycloverine is indicated in:

• Functional bowel/irritable bowel syndrome
• Urinary incontinence secondary to unstable detrusor muscle
• Infantile colic
• GIT spasm
• Colicky abdominal pain
• Diverticulitis
• Abdominal colic

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (Not For Intravenous Use). It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.

For oral dosage forms:

• Adults:10 to 20 mg three times a day.
• Children over 6 months of age: 5 to 10 mg three times a day.

For injectable dosage form:

• Adults: Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

Children: Dose must be determined by the doctor.

Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.

Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.

Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Colchicine are indicated for treatment of acute gout flares. And also indicated in Familial Mediterranean fever (FMF) in adults and children 4 years or older.

Drugs used in Gout

An acute attack of gout apparently occurs as a result of an inflammatory reaction to crystals of monosodium urate that are deposited in the joint tissue from hyperuric body fluids; the reaction is aggravated as more urate crystals accumulate. Leukocytes migrate to the sites where urate crystals have been deposited and try to engulf the crystals by phagocytosis. As a result lactic acid and proinflammatory enzymes are released which cause inflammation with severe pain, redness, and swelling of the affected joint. Lactic acid favors a local decrease in pH that enhances uric acid deposition. Colchicine inhibits the phagocytosis of uric acid by leukocytes & also diminishes the lactic acid production directly. Thus interrupts the cycle of urate crystal deposition and inflammatory response that sustains the acute attack of gout.

Colchicine is absorbed when given orally, reaching a mean Cmax of 2.5 ng/mL (range 1.1 to 4.4 ng/mL) in 1 to 2 hours after a single dose administered under fasting conditions. The mean apparent volume of distribution is approximately 5 to 8 L/kg. Colchicine binding to serum protein is low (39 ± 5%), primarily to albumin regardless of concentration. CYP3A4 is involved in the metabolism of Colchicine to 2-O-demethylcolchicine and 3-O-demethylcolchicine. Plasma levels of these metabolites are minimal (less than 5% of parent drug). Following multiple oral doses (0.6 mg twice daily), the mean elimination half-life is 26.6 to 31.2 hours.

Acute gouty arthritis:

• First dose- 1 to 1.2 mg (two 0.5 mg or two 0.6 mg tablets) at a time every 2 hours until pain and inflammation aborted.
• The total amount of colchicine needed to control pain and inflammation during an attack usually ranges from 4 to 8 mg.
• Articular pain and swelling typically reduced within 12 hours and are usually gone in 24 to 48 hours, An interval of three days between colchicine courses is advised in order to minimize the possibility of cumulative toxicity.

For prophylaxis during intercritical periods:

• To reduce the frequency of their severity, colchicine may be administered continuously.
• In patients who have less than one attack per year, the usual dose is 0.5 or 0.6 mg per day, three or four days a week.
• For cases involving more than one attack per year, the usual dose is 0.5 or 0.6 mg daily.
• Severe cases may require two or three 0.5 mg or 0.6 mg tablets daily.

For prophylaxis against attacks of gout in patients undergoing surgery:

• In patients with gout, an attack may be precipitated by even a minor surgical procedure. One 0.5 mg tablet or one 0.6 mg tablet three times daily should be administered for three days before and three days after surgery.

Blood dyscrasias: Myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, and aplastic anemia have been reported. Diarrhea and pharyngolaryngeal pain may occur.

Patients with renal or hepatic impairment should not be given Colchicine in conjunction with Permeability glycoprotein (P-gp) or strong CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine).

Co-administration of P-gp and/or CYP3A4 inhibitors (e.g., clarithromycin or cyclosporine) have been demonstrated to alter the concentration of Colchicine

Pregnancy Category C. There are no adequate and well-controlled studies with Colchicine in pregnant women. Colchicine is excreted into human milk. Caution should be exercised when administered to a nursing woman.

Pediatric Use: Gout is rare in pediatric patients. Safety and effectiveness of Colchicine in pediatric patients have not been established.

The exact dose of colchicine that produces significant toxicity is unknown. Fatalities have occurred after ingestion of a dose as low as 7 mg over a 4-day period, while other patients have survived after ingesting more than 60 mg. A review of 150 patients who overdosed on colchicine found that those who ingested less than 0.5 mg/kg survived and tended to have milder toxicities, such as gastrointestinal symptoms, whereas those who took 0.5 to 0.8 mg/kg had more severe reactions, such as myelosuppression.

Store below 30°C temperature. Protect from light and moisture. Keep the medicine out of reach of children.

হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির সমস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।

Anticholinergics (antimuscarinics)/ Anti-spasmodics

খাওয়ার জন্য-

• প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
• শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী। 

ইনজেকশন হিসেবে-

• প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।

হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।

যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।

সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।

সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়ে দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।

গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।

ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।

মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।  কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।

হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির সমস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।

Anticholinergics (antimuscarinics)/ Anti-spasmodics

খাওয়ার জন্য-

• প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
• শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী। 

ইনজেকশন হিসেবে-

• প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।

হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।

যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।

সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।

সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়ে দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।

গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।

ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।

মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।  কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।

হায়োসিন বিউটাইলব্রোমাইড একটি এন্টিকোলিনার্জিক ওষুধ, এবডোমিনাল ক্যাভিটির বিভিন্ন অংশের নরম মাংসপেশীর (smooth muscle) উপর যার খিঁচুনিবিরোধী (antispasmodic) ক্রিয়া রয়েছে। হায়োসিন বিউটাইলব্রোমাইড ট্যাবলেট গ্যাসট্রো ইন্টেসটিনাল ট্র্যাক্টে অথবা জেনিটো-ইউরিনারী ট্র্যাক্টের ভিসেরাল খিঁচুনি জনিত লক্ষণসমূহে নির্দেশিত। স্পাসমোডিক ডিসমেনোরিয়াতেও এটি নির্দেশিত। হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন গ্যাসট্রো-ইন্টেসটিনাল খিঁচুনি এবং রেনাল অথবা পিত্তের (billary) তীব্র ব্যথাতেও নির্দেশিত। রেডিওলজীতে প্রতিবন্ধকতার পার্থক্যমূলক রোগ নির্ণয়ে, পাইলোগ্রাফীতে খিঁচুনি ও ব্যথা কমাতে এবং গ্যাসট্রো-ডিওডেনাল এনডোস্কোপীর মত রোগ নির্ণয়ের অন্যান্য পদ্ধতিতেও খিঁচুনির সমস্যা দূর করার জন্য হায়োসিন বিউটাইলব্রোমাইড ইনজেকশন ব্যবহার করা হয়।

Anticholinergics (antimuscarinics)/ Anti-spasmodics

খাওয়ার জন্য-

• প্রাপ্ত বয়স্ক: ২০ মিগ্রা দিনে চার বার। স্পাসমোডিক ডিসমেনোরিয়ার ক্ষেত্রে ঋতুস্রাব (menstruation) শুরুর সম্ভাব্য তারিখের কমপক্ষে দুদিন আগে থেকে চিকিৎসা শুরু করতে হবে এবং স্রাব শুরুর তিনদিন পরে পর্যন্ত তা অব্যাহত রাখতে হবে।
• শিশু ৬ থেকে ১২ বৎসর পর্যন্ত: ১০ মিগ্রা দিনে তিনবার অথবা চিকিৎসকের নির্দেশ অনুযায়ী। 

ইনজেকশন হিসেবে-

• প্রাপ্তবয়স্ক: মাংসপেশীতে বা শিরাপথে প্রয়োগের জন্য সাধারণ মাত্রা হচ্ছে ২০ মিগ্রা (১টি এ্যাম্পুল), প্রয়োজনে যা কিনা ৩০ মিনিট পর পুনরায় প্রয়োগ করতে হবে। এনডোস্কোপীর ক্ষেত্রে এই মাত্রা আরো ঘন ঘন প্রয়োগ করতে হবে।

হায়োসিন বিউটাইলব্রোমাইড এর পার্শ্ব-প্রতিক্রিয়ার মধ্যে রয়েছে মুখ শুকিয়ে যাওয়া, পিউপিল এর প্রসরণ (dilatation), ইন্ট্রা-অকিউলার প্রেসার বৃদ্ধি, ফ্লাসিং, ত্বক শুকিয়ে যাওয়া, ব্র্যাডিকার্ডিয়া এবং তারপরেই ট্যাকিকার্ডিয়া ও এরিমিয়া। কখনো কখনো ক্লান্তি, বমি, মাথা ঝিমঝিম (giddiness) এবং ষ্ট্যাগারিং হতে পারে।

যে সব রোগীর প্রস্টেটিক বৃদ্ধি ঘটেছে তাদের ক্ষেত্রে এর ব্যবহার নিষিদ্ধ এবং বৃদ্ধদের ক্ষেত্রে এটি সতর্কতার সাথে ব্যবহার করতে হবে। যে সব রোগী প্যারালাইটিক ইলিয়াস অথবা পাইলোরিক ষ্টেনোসিসে ভুগছেন তাদের ক্ষেত্রেও ওষুধটির ব্যবহার নিষিদ্ধ। সম্ভাব্য মাইড্রিয়াটিক ক্ষতির কারণে যে সব রোগীর গ্লুকোমা রয়েছে তাদের ক্ষেত্রেও এটির ব্যবহার নিষিদ্ধ ।

সাবধানতা: হায়োসিন ঝিমুনি সৃষ্টি করতে পারে ও মানসিক সতর্কতা নিজে করে নিস্তেজ করে দিতে পারে। যে সকল রোগী হায়োসিন দিয়ে চিকিৎসাধীন রয়েছে তাদের গাড়ী বা অন্যান্য যানবাহন অথবা মানসিক একাগ্রতার অভাবে দুর্ঘটনা ঘটতে পারে এমন কোন যন্ত্রপাতি চালানো উচিত নয়। রোগীদের মদ্যপান করা থেকেও বিরত থাকা উচিত।

সতর্কতা: থাইরোটক্সিকোসিস, কার্ডিয়াক অপর্যাপ্ততা (insufficiency) বা ফেলিওর এবং হৃদপিন্ডে অস্ত্রোপচারের ক্ষেত্রে এই ওষুধ হৃদপিন্ডের গতি আরো বাড়িয়ে দিতে পারে বলে এর ব্যবহারে সতর্কতা অবলম্বন করা উচিত। অন্যান্য এন্টিকোলিনার্জিক ওষুধসমূহ যেমন এমানটেডিন, কোন কোন এন্টিহিস্টামিন, বিউটাইরোফেনন ও ফেনোথায়াজিন এবং ট্রাইসাইক্লিক এন্টিডিপ্রেসেন্ট হায়োসিনের সাথে একত্রে প্রয়োগের ফলে হায়োসিনের ক্রিয়া বেড়ে যেতে পারে বিধায় এ সব ক্ষেত্রে হায়োসিন ব্যবহার করতে হলে এর মাত্রা কমিয়ে নেয়া প্রয়োজন হতে পারে।

গর্ভাবস্থার প্রথম তিন মাসে অন্যান্য ওষুধের মতো একেও সতর্কতার সাথে ব্যবহার করতে হবে।

ডেক্সট্রান কিংবা ০.৯% সোডিয়াম ক্লোরাইড ইনজেকশনের তরল দিয়ে হায়োসিন বিউটাইলব্রোমাইড ইনজেকশনকে তরলীকরণ করা যাবে।

মেয়াদ উত্তীর্ণের পর ব্যবহার করবেন না। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।  কেবলমাত্র রেজিস্টার্ড চিকিৎসকের ব্যবস্থাপত্র অনুযায়ী বিতরণযোগ্য।

Other antibacterial preparation

Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistimethate is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.

Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.

• Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
• Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
• Creatinine clearance <10 ml/min: daily dose 3.5 MIU

Haemodialysis (HD) patients:

• No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
• HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.

Pediatric population: The dose should be based on lean body weight.

• Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
• Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.

Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.

Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for injection to one of the following:

• 0.9% NaCl
• 5% dextrose in 0.9% NaCl
• 5% dextrose in water
• 5% dextrose in 0.45% NaCl
• 5% dextrose in 0.225% NaCl
• Lactated Ringer's solution

There are not sufficient data to recommend usage of Colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.

The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.

The use of Colistimethate Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

Colistimethate should be used with caution in patient with impaired renal function. When actual renal impairment is present, Colistimethate may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Colistimethate should be used with caution in neonates, infants and children.

Colistimethate should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Colistimethate should be avoided.

There are no adequate and well-controlled studies about the use of Colistimethate in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Colistimethate is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Colistimethate Sodium therapy should be discontinued and general supportive measures should be utilized.

For IM injection: Reconstitute the contents of the vial with 2 ml water for injection only.
For bolus injection: Reconstitute the contents of the vial with 5 ml water for injection.
For infusion: The contents of the reconstituted vial may be diluted, usually with 50 ml-100ml 0.9% sodium chloride.

Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.

Other antibacterial preparation

Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistimethate is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.

Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.

• Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
• Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
• Creatinine clearance <10 ml/min: daily dose 3.5 MIU

Haemodialysis (HD) patients:

• No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
• HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.

Pediatric population: The dose should be based on lean body weight.

• Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
• Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.

Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.

Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for injection to one of the following:

• 0.9% NaCl
• 5% dextrose in 0.9% NaCl
• 5% dextrose in water
• 5% dextrose in 0.45% NaCl
• 5% dextrose in 0.225% NaCl
• Lactated Ringer's solution

There are not sufficient data to recommend usage of Colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.

The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.

The use of Colistimethate Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

Colistimethate should be used with caution in patient with impaired renal function. When actual renal impairment is present, Colistimethate may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Colistimethate should be used with caution in neonates, infants and children.

Colistimethate should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Colistimethate should be avoided.

There are no adequate and well-controlled studies about the use of Colistimethate in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Colistimethate is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Colistimethate Sodium therapy should be discontinued and general supportive measures should be utilized.

For IM injection: Reconstitute the contents of the vial with 2 ml water for injection only.
For bolus injection: Reconstitute the contents of the vial with 5 ml water for injection.
For infusion: The contents of the reconstituted vial may be diluted, usually with 50 ml-100ml 0.9% sodium chloride.

Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.

Calcitriol is indicated in-

• Post-menopausal osteoporosis
• Renal osteodystrophy
• Postsurgical hypoparathyroidism
• Idiopathic hypoparathyroidism
• Pseudohypoparathyroidism
• Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)
• Vitamin D dependent rickets

Vitamin in bone formation, Vitamin-D preparations

Calcitriol is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Calcitriol is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.

The optimal daily dose of Calcitriol capsule must be carefully determined for each patient on the basis of serum calcium level.

In Post-menopausal Osteoporosis: The recommended dose of Calcitriol capsule is 0.25 mcg twice daily.

In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Calcitriol capsule. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient.

In Hypoparathyroidism and Rickets: The recommended initial dosage of Calcitriol capsule is 0.25 mcg/day which given in the morning. If within 2-4 weeks satisfactory response is not observed by usual dose then dose may be increased at 2-4 weeks intervals.

The recommended intravenous initial dose of Calcitriol injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals.

Occasional symptoms include anorexia, headache, vomiting and constipation. Chronic effects may include dystrophy, fever, polyuria, dehydration, apathy and urinary tract infection.

Calcitriol is contraindicated in patients with known hypersensitivity to any of its ingredients. Calcitriol is also contraindicated in all diseases associated with hypercalcemia.

During Calcitriol therapy if the serum calcium levels rise to 1 mg/100 ml above normal or serum creatinine rises to >120 µmol/l, the dosage of Calcitriol should be substantially reduced or treatment stopped.

Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis as hypercalcemia in such patients may precipitate cardiac arrhythmias. Magnesium containing drugs (e.g.,antacids) may cause hypermagnesemia.

There is no evidence that vitamin D is teratogenic in humans. Calcitriol may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Calcitriol but serum calcium levels of the mother and infant should be monitored.

Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)-

• The recommended initial dosage of Calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age or older. This dosage may be increased if necessary to 0.5 mcg/day.
• For pediatric patients less than 3 years of age, the recommended initial dosage of Calcitriol is 10 to 15 ng/kg/day.
• In Elderly: No dosage adjustment are required.

keep in a dry place away from light and heat. Keep out of the reach of children.

Calcitriol is indicated in-

• Post-menopausal osteoporosis
• Renal osteodystrophy
• Postsurgical hypoparathyroidism
• Idiopathic hypoparathyroidism
• Pseudohypoparathyroidism
• Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)
• Vitamin D dependent rickets

Vitamin in bone formation, Vitamin-D preparations

Calcitriol is one of the most important active metabolites of vitamin D3. It is normally formed in the kidneys from its precursor, 25-hydroxycholecalciferol. Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The key role of Calcitriol is the regulation of calcium homeostasis, which includes stimulation effects on osteoblastic activity in the skeleton.

The optimal daily dose of Calcitriol capsule must be carefully determined for each patient on the basis of serum calcium level.

In Post-menopausal Osteoporosis: The recommended dose of Calcitriol capsule is 0.25 mcg twice daily.

In Renal Osteodystrophy (dialysis patients): The initial daily dose is 0.25 mcg of Calcitriol capsule. In patients with normal or only slightly reduced calcium levels, doses of 0.25 mcg every other day are sufficient.

In Hypoparathyroidism and Rickets: The recommended initial dosage of Calcitriol capsule is 0.25 mcg/day which given in the morning. If within 2-4 weeks satisfactory response is not observed by usual dose then dose may be increased at 2-4 weeks intervals.

The recommended intravenous initial dose of Calcitriol injection, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals.

Occasional symptoms include anorexia, headache, vomiting and constipation. Chronic effects may include dystrophy, fever, polyuria, dehydration, apathy and urinary tract infection.

Calcitriol is contraindicated in patients with known hypersensitivity to any of its ingredients. Calcitriol is also contraindicated in all diseases associated with hypercalcemia.

During Calcitriol therapy if the serum calcium levels rise to 1 mg/100 ml above normal or serum creatinine rises to >120 µmol/l, the dosage of Calcitriol should be substantially reduced or treatment stopped.

Concomitant treatment with a thiazide diuretics increases the risk of hypercalcemia. Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis as hypercalcemia in such patients may precipitate cardiac arrhythmias. Magnesium containing drugs (e.g.,antacids) may cause hypermagnesemia.

There is no evidence that vitamin D is teratogenic in humans. Calcitriol may be used during pregnancy only if the benefits outweigh the potential risk to the fetus. Mothers may breast feed while taking Calcitriol but serum calcium levels of the mother and infant should be monitored.

Secondary hyperparathyroidism in patients with moderate to severe chronic renal failure (pre-dialysis)-

• The recommended initial dosage of Calcitriol is 0.25 mcg/day in adults and pediatric patients 3 years of age or older. This dosage may be increased if necessary to 0.5 mcg/day.
• For pediatric patients less than 3 years of age, the recommended initial dosage of Calcitriol is 10 to 15 ng/kg/day.
• In Elderly: No dosage adjustment are required.

keep in a dry place away from light and heat. Keep out of the reach of children.

Peppermint Oil is indicated in Irritable bowel syndrome (IBS), Functional dyspepsia, Abdominal pain and spasm, Abdominal distension/bloating

Anticholinergics (antimuscarinics)/ Anti-spasmodics, Herbal and Nutraceuticals

Peppermint Oil helps to relieve both the painful abdominal spasm and uncomfortable bloating of IBS. It has a relaxant, antispasmodic effect especially on the muscles of the large bowel or colon and in bowel spasm, particularly large-bowel spasm. It is carminative, antibacterial, mucolytic. Peppermint Oil helps to treat unpleasant sensations of fullness and bloating and facilitates the passing of bowel gases, so relieving accompanying cramp like pain.

Adults: 1 capsule 3 times daily with a glass of water. The dose may be increased to a maximum of 2 capsules 3 times daily or as directed by a physician.

Children (8 years and above): 1 capsule 3 times daily with a glass of water or a directed by a physician.

Contraindicated in patients with achlorhydria. Also contraindicated for infants due to the potential risk of spasm of the tongue or respiratory arrest.

Should not be taken with food or immediately after meals. Should be taken 30 to 60 minutes before meals. Must be swallowed whole, with a little liquid. Capsules must not be chewed or crushed.

Exacerbation of adverse effects if taken with alcohol; enteric-coated preparations containing peppermint oil should not be taken immediately with antacids.

No known restrictions.

Keep in a cool & dry place, away from direct sunlight. Keep out of reach of children.

Mebeverine is indicated for the:

• Symptomatic treatment of irritable bowel syndrome (IBS)
• Chronic irritable colon
• Spastic constipation
• Mucous colitis
• Colicky abdominal pain
• Persistent non-specific diarrhoea

Anticholinergics

For adults, elderly and children over 10 years:

• Mebeverine Hydrochloride 135 mg tablet: 1 tablet 03 times daily.
• Mebeverine Hydrochloride 200 mg capsule: 1 capsule 02 times daily.

This is most effective when taken 20 minutes before meals. After several weeks when the desired effect has been obtained, the dosage may be gradually reduced.

Missed dose: If a dose of this medicine is missed, that should be taken as soon as possible. However, if it is almost time for the next dose, then skip the missed dose and the regular dosing schedule should be maintained. Dose should not be doubled at the same time to compensate the missed dose.

Use in children: Mebeverine is not recommended for children under 10 years.

Generally Mebeverine is well tolerated. However, few side-effects like skin rash, urticaria and angioedema may appear

Hypersensitivity to the drug or any other ingredients.

Caution should be exercised in porphyria or allergic reaction to this or any other medicine of this group.

No teratogenicity has been shown in animal experiments. However, the usual precautions concerning the administration of any drug during pregnancy should be exercised. Mebeverine does not excrete in the breast milk after administering at therapeutic dose.

On theoretical grounds it may be predicted that CNS excitability will occur in case of overdosage. No specific antidote is known: gastric lavage and symptomatic treatment is recommended

Do not store above 30°C. Keep away from light and out of the reach of children.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Primary hypercholesterolaemia and combined hyperlipidaemia-

• Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.

Familial hypercholesterolaemia-

• Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.

Prevention of cardiovascular events-

• Adults: Initially 10 mg once daily adjusted according to response.

Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.

Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.

Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Other Anti-anginal & Anti-ischaemic drugs, Statins

Atorvastatin is a selective inhibitor of HMG-CoA reductase. This enzyme is the rate-limiting enzyme responsible for the conversion of HMG-CoA to mevalonate, a precursor of sterols, including cholesterol. Atorvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.

Primary hypercholesterolaemia and combined hyperlipidaemia-

• Adults: Usually 10 mg once daily; if necessary, may be increased at intervals of at least 4 weeks to max. 80 mg once daily.
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 20 mg once daily.

Familial hypercholesterolaemia-

• Adults: Initially 10 mg daily, increased at intervals of at least 4 weeks to 40 mg once daily; if necessary, further increased to max. 80 mg once daily (or 40 mg once daily combined with anion-exchange resin in heterozygous familial hypercholesterolaemia).
• Child (10-18 years): Initially 10 mg once daily, increased if necessary at intervals of at least 4 weeks to usual max. 80 mg once daily.

Prevention of cardiovascular events-

• Adults: Initially 10 mg once daily adjusted according to response.

Atorvastatin is generally well-tolerated. The most frequent side effects related to Atorvastatin are constipation, flatulence, dyspepsia, abdominal pain. Other side effects includes infection, headache, back pain, rash, asthenia, arthralgia, myalgia.

Atorvastatin should not be used in patient with hypersensitivity to any component of this medication. Atorvastatin is contraindicated in active liver disease or unexplained persistent elevations of serum transaminases. It is also contraindicated in patient with history of serious adverse reaction to prior administration of HMG-CoA reductase inhibitors.

Liver effects: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol or have a history of liver disease. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected.

The risk of myopathy during treatment with Atorvastatin is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, azole antifungals and niacin. No clinically significant interactions were seen when Atorvastatin was administered with antihypertensives or hypoglycemic agents. Patients should be closely monitored if Atorvastatin is added to digoxin, erythromycin, oral contraceptives, colestipol, antacid and warfarin.

Pregnancy: Atorvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction. Maternal treatment with atorvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with atorvastatin should be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant

Lactation: It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breastfeed their infants. Atorvastatin is contraindicated during breastfeeding.

Hepatic impairment: Atorvastatin should be used with caution in patients with hepatic impairment.

Pediatric use: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day. Atorvastatin is not indicated in the treatment of patients below the age of 10 years.

Specific treatment is not available for atorvastatin overdose. The patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should be performed and serum CK levels should be monitored. Due to extensive atorvastatin binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin clearance.

Keep in a dry place away from light and heat. Keep out of the reach of children.