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Remathrin
Permethrin
Remathrin
Permethrin
Indications
Scabies
Indication detailsView
Permethrin cream is indicated for the treatment of scabies and crab lice infestations (Pediculosis). Scabies can affect everyone in the family. If one is infected, all family members must be treated together.
Therapeutic classView
Parasiticidal preparations
PharmacologyView
Permethrin cream contains Permethrin, a pyrethroid, which is a topical scabicidal agent for the treatment of infestation with Sarcoptes Scabiei (scabies). It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization & paralysis of the pests are the consequences of this disturbance.
Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.
Pharmacokinetics: The only approved route of administration is the topical route and there are few human data available on systemic exposure or kinetics following permethrin application to the skin. Some presystemic metabolism occurs in skin. Less than 0.5% of applied permethrin is absorbed during the first 48 hours. Absorbed permethrin is rapidly metabolized by ester hydrolysis, most likely in the liver and the products are excreted primarily in the urine.
DosageView
Recommended duration of Treatment:
- Adults and children over 12 years: a full tube
- Children aged 6-12 years: up to 1⁄2 of a tube
- Children aged 1-5 years: up to ¼ of a tube
- Children aged 2 months to 1 year: up to ⅛ of a tube
- Children Less then 2 month: dose is not established
AdministrationView
Before application of Permethrin cream the skin should be clean, cool and dry. Do not have a hot shower or bath before applying.
For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.
For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth.
Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, permethrin cream should be used again after 7 days as per the advice of the doctor.
For adults and children over 2 years: Apply the cream to the whole body from the neck down, rubbing lightly into the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.
For babies under 2 years: Apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth.
Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8h treatment time (such as after washing the hands). If necessary, permethrin cream should be used again after 7 days as per the advice of the doctor.
Side effectsView
In Scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Others transient signs and symptoms of irritation including enythema, edema, eczema, rash and puritis.
ContraindicationsView
Permethrin is contraindicated in patients with known hypersensitivity to any component of pyrethroids or permethrin. Nursing staff who routinely apply permethrin may wear globes to avoid any possible irritation to the hands.
PrecautionsView
Scabies infestation is often accompanied by pruritus, edema & erythema. Treatment with permethrin may temporarily exacerbate these conditions. Patients should be advised to avoid contact with eyes during application & to flash with water immediately if the cream gets in the eyes.
InteractionsView
The treatment of eczemodous like reactions with corticosteroids should be withheld prior to treatment with permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.
Pregnancy & lactationView
In the absence of specific studies in pregnant women, its use in pregnancy should only follow medical advice. It is not known whether permethrin is excreted in human milk so it should not be used in nursing mothers.
StorageView
Store in a cool, dry place, away from light & keep out of the reach of children...
Remave SR
Aceclofenac
Remave SR
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Remavit-M
Multivitamin & Multimineral
Remavit-M
Multivitamin & Multimineral
Indications
Vitamin deficiency
Indication detailsView
This is indicated for the treatment and/or prevention of vitamin and mineral deficiencies associated with restricted diets, improper food intake, alcoholism and decreased absorption. It is also indicated in patients with increased requirements for vitamins and minerals due to acute and chronic diseases, pregnancy, lactation, menopause, infections, during treatment with antibiotics, convalescence etc. To prevent the occurrence of serious birth defects periconceptional (from three months before conception up to the first trimester of pregnancy) supplementation with this tablet is required.
Therapeutic classView
Multi-vitamin & Multi-mineral combined preparations, Specific mineral & vitamin combined preparations
PharmacologyView
Vitamins and minerals are essential for normal metabolic functions including hematopoiesis. The members of vitamin B-group are components of enzyme system that regulate various stages of carbohydrate, fat and protein metabolism, each of the components playing a specific biological role. Vitamin C is involved in tissue repair and collagen formation. Vitamin A plays an essential role in the function of retina and is essential for growth and differentiation of epithelial tissue. Vitamin E is an antioxidant which preserves essential cellular constituents. Vitamin D is supplemented for prevention and cure of nutritional and metabolic rickets and for treatment of hypoparathyroidism. Iron, Copper, Manganese, Zinc serve as catalysts in enzyme systems which perform vital cellular functions.
DosageView
Orally one tablet daily for adult and children over 5 years of age or as directed by the physicians.
Side effectsView
Side effects have been reported with specific vitamins & minerals, but at level substantially higher than those in this tablet. Iron has been associated with gastrointestinal intolerance in some patients.
ContraindicationsView
This is contraindicated in patients hypersensitive to any of its components. This is not intended for treatment of severe specific deficiencies of vitamins or minerals. It is not recommended for patients undergoing treatment with levodopa as pyridoxine decreases the efficacy of levodopa. During the first trimester of pregnancy, larger doses of vitamin A (more than 10 tablets per day) may be teratogenic.
PrecautionsView
Not intended for treatment of pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.
Pregnancy & lactationView
During the first trimester of pregnancy, recommended daily dose should not be exceeded. Because larger doses of Vitamin-A (multiple tablets per day) may be teratogenic.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Remazin
Diethylcarbamazine Citrate
Remazin
Diethylcarbamazine Citrate
Indications
Toxocariasis
Indication detailsView
Diethylcarbamazine is indicated for Filariasis, Lymphatic filariasis, Pulmonary eosinophilia, Loiasis, Toxocariasis.
Therapeutic classView
Other Anti-protozoals
PharmacologyView
The mechanism of action of diethylcarbamazine is thought to involve sensitizing the microfilariae to phagocytosis. One study showed that diethylcarbamazine's activity against Brugia malayi microfilariae is dependent on inducible nitric-oxide synthase and the cyclooxygenase pathway. It confirmed the important role of the arachidonic acid metabolic pathway in diethylcarbamazine's mechanism of action in vivo and showes that in addition to its effects on the 5-lipoxygenase pathway, it targets the cyclooxygenase pathway and COX-1.
DosageView
Inital: 1 mg/kg/day, may increase to 6 mg/kg/day over 3 days, then maintain for 3 wk. Prophylaxis of loiasis 300 mg/wk.
Side effectsView
Fever, headache, vomiting, dizziness, drowsiness, nausea, chills.
Potentially Fatal: Severe hypersensitivity reactions may occur especially in the treatment of onchocerciasis where rare Mazzotti reaction characterised by rash, itching, headache, muscle and joint pains, tachycardia, postural hypotension may start within 2 hr of drug administration. Encephalitis and retinal haemorrhage.
Potentially Fatal: Severe hypersensitivity reactions may occur especially in the treatment of onchocerciasis where rare Mazzotti reaction characterised by rash, itching, headache, muscle and joint pains, tachycardia, postural hypotension may start within 2 hr of drug administration. Encephalitis and retinal haemorrhage.
ContraindicationsView
Pregnancy, hypersensitivity; lactation; infants, elderly or debilitated patients; impaired renal function; cardiac disease.
PrecautionsView
Patients with poor health.
Lactation: not known if excreted in breast milk
Lactation: not known if excreted in breast milk
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
Pregnancy Category- X. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Rembac
Baclofen
Rembac
Baclofen
Indications
Trigeminal neuralgia
Indication detailsView
Baclofen is indicated in-
- spasticity resulting from multiple sclerosis
- flexor spasms and concomitant pain, clonus and muscular rigidity
- skeletal muscle spasm resulting from rheumatic disorders
- spinal cord injuries and other spinal cord diseases
- cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.
Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
Children <10 years: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
- 12 month-2 years: 10-20 mg (10-20 ml)
- 2 years-6 years: 20-30 mg (20-30 ml)
- 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
- Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
- Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
- Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
- Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
- Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
- Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
- Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
- In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
- Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
- Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
- During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
- Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
- Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
- Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
- Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
- The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
- In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
- The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
- Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Remcor
Remdesivir
Remcor
Remdesivir
Indications
Suspected or confirmed COVID-19
Indication detailsView
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Therapeutic classView
Anti-viral drugs
PharmacologyView
Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
DosageView
General Information-
- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
AdministrationView
The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
Infusion bag 250 ml:
- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
Side effectsView
An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
ContraindicationsView
Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
PrecautionsView
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Pregnancy & lactationView
No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
ReconstitutionView
Reconstitution instructions:
- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
- Immediately shake the vial for 30 seconds.
- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
StorageView
Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Remdevir
Remdesivir
Remdevir
Remdesivir
Indications
Suspected or confirmed COVID-19
Indication detailsView
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Therapeutic classView
Anti-viral drugs
PharmacologyView
Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
DosageView
General Information-
- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
AdministrationView
The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
Infusion bag 250 ml:
- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
Side effectsView
An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
ContraindicationsView
Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
PrecautionsView
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Pregnancy & lactationView
No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
ReconstitutionView
Reconstitution instructions:
- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
- Immediately shake the vial for 30 seconds.
- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
StorageView
Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Remdigen
Remdesivir
Remdigen
Remdesivir
Indications
Suspected or confirmed COVID-19
Indication detailsView
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Therapeutic classView
Anti-viral drugs
PharmacologyView
Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
DosageView
General Information-
- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
AdministrationView
The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
Infusion bag 250 ml:
- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
Side effectsView
An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
ContraindicationsView
Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
PrecautionsView
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Pregnancy & lactationView
No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
ReconstitutionView
Reconstitution instructions:
- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
- Immediately shake the vial for 30 seconds.
- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
StorageView
Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Remdinil
Remdesivir
Remdinil
Remdesivir
Indications
Suspected or confirmed COVID-19
Indication detailsView
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Therapeutic classView
Anti-viral drugs
PharmacologyView
Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
DosageView
General Information-
- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
AdministrationView
The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
Infusion bag 250 ml:
- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
Side effectsView
An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
ContraindicationsView
Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
PrecautionsView
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Pregnancy & lactationView
No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
ReconstitutionView
Reconstitution instructions:
- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
- Immediately shake the vial for 30 seconds.
- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
StorageView
Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Remens
Norethisterone Acetate
Remens
Norethisterone Acetate
Indications
Premenstrual syndrome
Indication detailsView
Norethisterone is indicated in:
- Metropathia hemorrhagic (dysfunctional uterine bleeding),
- Premenstrual syndrome,
- Postponement of menstruation,
- Endometriosis &
- Menorrhagia.
Therapeutic classView
Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive preparations
PharmacologyView
Norethisterone tablet is a preparation of Norethisterone which has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak estrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle. Norethisterone is absorbed from the gastrointestinal tract and its effects last for at least 24 hours. It is excreted in the urine.
DosageView
Oral administration. Not intended for use in children.
Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment.
Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily) recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle.
Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 2-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months.
Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, sports) the postponement of menstruation is possible. 1 tablet of Norethisterone three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets.
Endometriosis (pseudo-pregnancy therapy): Long-term treatment is commenced on the 5th day of the cycle with 2 tablets of Norethisterone daily for the first few weeks. In the event of spotting, the dosage is increased to 4, and, if necessary, 5 tablets daily. After bleeding has ceased, the initial dose is usually sufficient. Duration of treatment: 4-6 months continuously, or longer if necessary.
Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day 1).
Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment.
Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily) recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle.
Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 2-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months.
Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g. operations, travel, sports) the postponement of menstruation is possible. 1 tablet of Norethisterone three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets.
Endometriosis (pseudo-pregnancy therapy): Long-term treatment is commenced on the 5th day of the cycle with 2 tablets of Norethisterone daily for the first few weeks. In the event of spotting, the dosage is increased to 4, and, if necessary, 5 tablets daily. After bleeding has ceased, the initial dose is usually sufficient. Duration of treatment: 4-6 months continuously, or longer if necessary.
Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day 1).
Side effectsView
Side-effects are more common during the first months after start of intake of Norethisterone, and subside with a duration of treatment. The side-effects are mentioned below:
- Eye disorders- Visual disturbance
- GI disorders- Nausea
- General disorders and administration site- conditions headache, edema
- Nervous system disorders- Migraine, Respiratory, thoracic and mediastinal disorders- Dyspnoea,
- Skin and subcutaneous tissue disorders- Hypersensitivity (eg. Rash, urticaria).
ContraindicationsView
- Pregnancy
- Severe disturbances of liver function
- Dubin-Johnson syndrome
- Rotor syndrome
- Previous or existing liver tumours
- History during pregnancy of idiopathic jaundice, severe pruritus or herpes gestationis
- Current thromboembolic processes
- Hypersensitivity to the active substances or to any of the excipients
PrecautionsView
There is a general opinion, based on statistical evidence that users of combined oral contraceptives experience, more often than non-users, venous thromboembolism, arterial thrombosis, including cerebral and myocardial infarction and subarachnoid haemorrhage. Full recovery from such disorders does not always occur, and it should be realized that in a few cases they are fatal. Although Norethisterone does not contain oestrogen, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic disease or in the presence of severe diabetes with vascular changes or sickle-cell anaemia.
In rare cases benign, and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Norethisterone. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
Norethisterone can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment.
Reasons for stopping Norethisterone immediately-
In rare cases benign, and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Norethisterone. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
Norethisterone can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment.
Reasons for stopping Norethisterone immediately-
- Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches
- Sudden perceptual disorders (e.g. disturbances of vision or hearing)
- First signs of thrombophlebitis or thromboembolic symptoms, feeling of pain and tightness in the chest
- Pending operations (six weeks beforehand), immobilisation (e.g. after accidents)
- Onset of jaundice, hepatitis, general pruritus
- Significant rise in blood pressure
- Pregnancy.
InteractionsView
Not known.
Pregnancy & lactationView
The administration of Norethisterone during pregnancy is contraindicated. Norethisterone should not be used during lactation.
Overdose effectsView
There have been no reports from overdosage and treatment is generally unnecessary. There are no special antidotes and treatment should be symptomatic.
StorageView
Store below 30°C in a cool & dry place. Keep out of reach of children.
Remet
Metronidazole
Remet
Metronidazole
Indications
Vaginal trichomoniasis
Indication detailsView
Metronidazole is indicated in the treatment of following diseases:
- The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
- The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
- In the treatment of urogenital trichomoniasis.
- Bacterial vaginosis (also known as non-specific vaginitis).
- All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
- Giardiasis.
- Acute ulcerative gingivitis.
- Anaerobically infected leg ulcers and pressure sores.
- Acute dental infections due to anaerobic organisms.
- Antibiotic associated pseudomembranus colitis.
Therapeutic classView
Amoebicides, Anti-diarrhoeal Antiprotozoal
PharmacologyView
Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action of Metronidazole.
DosageView
Tablet and Suspension:
Trichomoniasis (Adults & Children over 10 yrs)-- 200 mg tid or 400 mg bid for 7 days
- 800 mg in the morning and 1-2 gm at night for 2 days
- 2 gm as a single dose for 1 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 800 mg tid for 5 days
- Children 7-10 yrs: 400 mg tid
- Children 3-7 yrs: 200 mg qid
- Children 1-3 yrs: 200 mg tid
- 400-800 mg tid for 5-10 days
- Children 7-10 yrs: 200-400 mg tid
- Children 3-7 yrs: 100-200 mg qid
- Children 1-3 yrs: 100-200 mg tid
- 2 gm once daily for 3 days
- Children 7-10 yrs: 1 gm once daily
- Children 3-7 yrs: 600-800 mg once daily
- Children 1-3 yrs: 500 mg once daily
- 200 mg tid for 3 days
- Children 7-10 yrs: 100 mg tid
- Children 3-7 yrs: 100 mg bid
- Children 1-3 yrs: 50 mg tid
- 200 mg tid for 3-7 days
- 400 mg bid for 7 days
- 2 gm as a single dose for 1 days
- 400 mg tid for 7 days
- 800 mg initially and then 400 mg tid for 7 days
- Children 1-10 yrs: 7.5 mg/kg tid
- 400 mg tid started 24 hours before surgery for 1 days
- Children 1-10 yrs: 7.5 mg/kg tid
Vaginal Gel:
The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered at bedtime.
Suppository:
Anaerobic Infections-- Adults: 1 g every 8 hours for 3 days, then 1 g every 12 hours.
- Children: 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours, Over 10 years adult dose.
- Adults: 1 g 2 hours before surgery; up to 3 further doses of 1 g may be given every 8 hours for high risk procedures.
- Children: 5-10 years: 500 mg 2 hours before surgery; up to 3 further doses of 500 mg may be given every 8 hours for high risk procedures.
IV Infusion:
Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.- Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
- Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.
Side effectsView
Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.
ContraindicationsView
Metronidazole is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
PrecautionsView
- If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
- Metronidazole should be administered with caution to patients with hepatic encephalopathy.
- Patients should be warned that metronidazole may darken urine.
InteractionsView
- Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
- Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
- Lithium: Plasma levels of lithium may be increased by metronidazole.
- Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
- Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
- 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
- Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.
Pregnancy & lactationView
US FDA Pregnancy Category of Metronidazole is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.
Pediatric usageView
Hepatic impairment: Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Metronidazole should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that metronidazole may darken urine.
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Renal impairment: The elimination half-life of metronidazole remains unchanged in the presence of renal failure. The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present. In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Metronidazole need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Overdose effectsView
Single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for metronidazole overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.
StorageView
Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.
Remicade
Infliximab
Remicade
Infliximab
Indications
Ulcerative colitis
Indication detailsView
Crohn’s Disease:
- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
- Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
- Reducing signs and symptoms in patients with active disease.
- Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.
- Treatment of adult patients with chronic severe (i.e., extensive and /or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Therapeutic classView
Targeted Cancer Therapy
PharmacologyView
Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. Infliximab does not neutralize TNFα (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα include: induction of pro inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNFα bound by infliximab can be lysed in vitro or in vivo. Infliximab inhibits the functional activity of TNFα in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which Infliximab exerts its clinical effects is unknown. Anti-TNFα antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab prevents disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα, and when administered after disease onset, allows eroded joints to heal.
DosageView
Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
Pediatric Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Pediatric Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Rheumatoid Arthritis: In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10
mg/kg or treating as often as every 4 weeks.
Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Pediatric Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Pediatric Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Rheumatoid Arthritis: In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10
mg/kg or treating as often as every 4 weeks.
Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
AdministrationView
Infliximab is administered by intravenous infusion over a period of not less than 2 hours.
Side effectsView
Most common adverse reactions (>10%)- infections (e.g. upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
ContraindicationsView
Infliximab doses >5 mg/kg in moderate to severe heart failure. Previous severe hypersensitivity reaction to Infliximab or known hypersensitivity to inactive components of Infliximab or to any murine proteins.
PrecautionsView
Serious infections- do not give Infliximab during an active infection. If an infection develops, monitor carefully and stop Infliximab if infection becomes serious.
Invasive fungal infections- for patients who develop a systemic illness on Infliximab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic
Malignancies- the incidence of malignancies including lymphoma was greater in Infliximab treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment.
Hepatitis B virus reactivation- test for HBV infection before starting Infliximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Infliximab and begin anti-viral therapy.
Hepatotoxicity- rare severe hepatic reactions, some fatal or
necessitating liver transplantation. Stop Infliximab in cases of jaundice and/or marked liver enzyme elevations.
Heart failure- new onset or worsening symptoms may occur.
Cytopenias- advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping Infliximab.
Hypersensitivity- serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur.
Demyelinating disease- exacerbation or new onset may occur.
Lupus-like syndrome- stop Infliximab if syndrome develops.
Live vaccines or therapeutic infectious agents- should not be given with Infliximab. Bring pediatric patients
Invasive fungal infections- for patients who develop a systemic illness on Infliximab, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic
Malignancies- the incidence of malignancies including lymphoma was greater in Infliximab treated patients than in controls. Due to the risk of HSTCL carefully assess the risk/benefit especially if the patient has Crohn’s disease or ulcerative colitis, is male, and is receiving azathioprine or 6-mercaptopurine treatment.
Hepatitis B virus reactivation- test for HBV infection before starting Infliximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Infliximab and begin anti-viral therapy.
Hepatotoxicity- rare severe hepatic reactions, some fatal or
necessitating liver transplantation. Stop Infliximab in cases of jaundice and/or marked liver enzyme elevations.
Heart failure- new onset or worsening symptoms may occur.
Cytopenias- advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping Infliximab.
Hypersensitivity- serious infusion reactions including anaphylaxis or serum sickness-like reactions may occur.
Demyelinating disease- exacerbation or new onset may occur.
Lupus-like syndrome- stop Infliximab if syndrome develops.
Live vaccines or therapeutic infectious agents- should not be given with Infliximab. Bring pediatric patients
InteractionsView
Use with anakinra or abatacept- increased risk of serious infections
Pregnancy & lactationView
Pregnancy Category B. It is not known whether Infliximab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
It is not known whether Infliximab is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Infliximab, women should not breast-feed their infants while taking Infliximab.
It is not known whether Infliximab is excreted in human milk or absorbed systemically after ingestion. Because many drugs and immunoglobulins are excreted in human milk, and because of the potential for adverse reactions in nursing infants from Infliximab, women should not breast-feed their infants while taking Infliximab.
Pediatric usageView
Pediatric Use: Infliximab has not been studied in children with Crohn’s disease or ulcerative colitis<6 years of age.
StorageView
Infliximab must be refrigerated at 2ºC to 8ºC. Do not use Infliximab beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.
Remicov
Remdesivir
Remicov
Remdesivir
Indications
Suspected or confirmed COVID-19
Indication detailsView
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Therapeutic classView
Anti-viral drugs
PharmacologyView
Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
DosageView
General Information-
- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
AdministrationView
The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
Infusion bag 250 ml:
- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
Side effectsView
An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
ContraindicationsView
Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
PrecautionsView
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Pregnancy & lactationView
No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
ReconstitutionView
Reconstitution instructions:
- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
- Immediately shake the vial for 30 seconds.
- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
StorageView
Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Remivir
Remdesivir
Remivir
Remdesivir
Indications
Suspected or confirmed COVID-19
Indication detailsView
Emergency use of Remdesivir for treatment of suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease is defined as patients with an oxygen saturation (Sp02) <94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Specifically, Remdesivir is only authorized for hospitalized adult and pediatric patients for whom use of an intravenous agent is clinically appropriate.
Therapeutic classView
Anti-viral drugs
PharmacologyView
Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.
DosageView
General Information-
- Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
- Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
- Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.
- The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
- The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
- The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
- For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
- For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).
AdministrationView
The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg
Infusion bag 250 ml:
Infusion bag 250 ml:
- Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
- Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min
- Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
- Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
- Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min
Side effectsView
An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.
ContraindicationsView
Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.
PrecautionsView
There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.
Pregnancy & lactationView
No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.
ReconstitutionView
Reconstitution instructions:
- Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
- Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
- Immediately shake the vial for 30 seconds.
- Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
- If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
- Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
- Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.
StorageView
Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.
After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.
Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).
Remmo
Esomeprazole (MUPS tablet)
Remmo
Esomeprazole (MUPS tablet)
Indication detailsView
Esomeprazole MUPS tablet is indicated in:
- Gastro-esophageal Reflux Disease (GERD).
- Risk reduction in NSAID associated gastric ulcer.
- H. pylori eradication (Triple therapy).
- Zollinger-Ellison syndrome and idiopathic hypersecretion.
PharmacologyView
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.
DosageView
Erosive esophagitis-
Children 1-11 years:
- Adult (≥18 years): 40 mg once daily for 4 weeks.
- Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.
- Adult (≥18 years): 20 mg once daily.
- Children & adolescents (12-18 years): 20 mg once daily.
- Adult (≥18 years): 20 mg once daily for 4-8 weeks.
- Adult (≥18 years): 20 mg twice daily for 7 days.
- Children & adolescents (12-18 years): 20 mg twice daily for 7 days.
- Adult (≥18 years): 40-80 mg twice daily.
Children 1-11 years:
- Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
- Maintenance of healing of erosive esophagitis: 10 mg once daily
AdministrationView
Esomeprazole MUPS tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. If required, the tablets can also be dispersed in half a glass of non-carbonated water (mineral water is not suitable). No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
Side effectsView
The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
ContraindicationsView
Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.
PrecautionsView
Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.
InteractionsView
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Pregnancy & lactationView
The manufacturer advises caution. It is not known if Esomeprazole or its metabolites appear in human breast milk.
StorageView
Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.
Remmo
Esomeprazole (MUPS tablet)
Remmo
Esomeprazole (MUPS tablet)
Indication detailsView
Esomeprazole MUPS tablet is indicated in:
- Gastro-esophageal Reflux Disease (GERD).
- Risk reduction in NSAID associated gastric ulcer.
- H. pylori eradication (Triple therapy).
- Zollinger-Ellison syndrome and idiopathic hypersecretion.
PharmacologyView
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase in the gastric parietal cell. Esomeprazole (S-isomer of omeprazole) is the first single optical isomer of proton pump inhibitor, provides better acid control than racemic proton pump inhibitors.
DosageView
Erosive esophagitis-
Children 1-11 years:
- Adult (≥18 years): 40 mg once daily for 4 weeks.
- Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.
- Adult (≥18 years): 20 mg once daily.
- Children & adolescents (12-18 years): 20 mg once daily.
- Adult (≥18 years): 20 mg once daily for 4-8 weeks.
- Adult (≥18 years): 20 mg twice daily for 7 days.
- Children & adolescents (12-18 years): 20 mg twice daily for 7 days.
- Adult (≥18 years): 40-80 mg twice daily.
Children 1-11 years:
- Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
- Maintenance of healing of erosive esophagitis: 10 mg once daily
AdministrationView
Esomeprazole MUPS tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. If required, the tablets can also be dispersed in half a glass of non-carbonated water (mineral water is not suitable). No other liquids should be used. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.
Side effectsView
The most frequently occurring adverse events reported with Esomeprazole include headache, diarrhoea, nausea, flatulence, abdominal pain, constipation and dry mouth. There are no difference in types of related adverse events seen during maintenance treatment upto 12 months compared to short term treatment.
ContraindicationsView
Esomeprazole is contraindicated in patient with known hypersensitivity to any of the formulation.
PrecautionsView
Esomeprazole should be used carefully if the patient has severe liver dysfunction and severe renal impairment. Taking a proton pump inhibitor like Esomeprazole may slightly increase the risk of hip, wrist and spine fracture, particularly when it is taken over a period of more than one year.
InteractionsView
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that Esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that Esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Esomeprazole may potentially interfere with CYP2C19, the major Esomeprazole metabolizing enzyme. Co-administration of Esomeprazole 30 mg anddiazepam, a CYP2C19 substrate has resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam have been observed 12 hours after dosing and onwards. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
Co-administration of oral contraceptives, diazepam, phenytoin, or quinidine do not seem to change the pharmacokinetic profile of Esomeprazole.
Combination Therapy with Clarithromycin: Co-administration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of esomeprazole and 14-hydroxyclarithromycin.
Pregnancy & lactationView
The manufacturer advises caution. It is not known if Esomeprazole or its metabolites appear in human breast milk.
StorageView
Store in a cool & dry place below 25ºC, protect from light. Keep out of reach of children.
Remocof
Herbal cough syrup [Adhatoda Vasica]
Remocof
Herbal cough syrup [Adhatoda Vasica]
Indications
Whooping cough
Indication detailsView
This herbal cough syrup liquefies phlegm. It soothes irritation of the throat. Helps to relieve hoarseness. It is a remedy for all types of cough such as dry irritable cough, allergic & smokers cough.
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
- Adhatoda vasica (Basok): Relieves cough & bronchial spasm. It liquefies mucous.
- Piper longum (Pipul): Relieves cold allergy & asthma.
- Glycyrrhiza glabra (Jashthi Modhu) : Relieves irritation of throat. Enhances the immune system. It is anti-inflammatory, demulcent & expectorant.
- Piper nigrum (Marich): It is fungistatic, bacteriostatic & anti-inflammatory.
- Zingiber officinale (Shunthi): It is antihistaminic. Very much effective in common cold.
- Terminalia chebula (Haritaki): It removes toxin from the body. It has beneficial effect on all tissues.
- Vitis venifera (Kismiss): Relieves cough and general tonic.
- Acorus calamus (Bacha): Helps in bronchial catarrh & intermittent fever.
- Saussurea lappa (Kur): It is antiseptic & disinfectant. It is very useful in bronchial asthma.
- Syzygium aromaticum (Labango): Useful in cough & other respiratory diseases. It prevents bad breath.
- Cinnamomum zeylanicum (Darchini): It is antibacterial & antifungal and relieves cough due to its soothing action.
- Elettaria cardamomum (Elachi): It is aromatic in nature and shows antimicrobial activity.
- Cinnamomum tamala (Tejpata): It is a tonic & appetizer agent.
- Pistacia integerrima (Kakra sringi): It helps in asthma.
- Myrica nagi ( Kotfal): It is a remedy for sore throat.
- Woodfordia fruticosa (Daiful): It is good anti-infective agent and is useful in relieving cough due to its soothing action.
- Tulsi extract & other ingredients: Tulsi extract & some other ingredients are added to DEVAS syrup for relieving acute cough.
DosageView
Children under 12 years: 1-2 teaspoonful (5-10 ml) 2-3 times a day. '
Adult: 3 teaspoonful (15 ml) 2-3 times a day.
Some warm water may be added for better results.
Adult: 3 teaspoonful (15 ml) 2-3 times a day.
Some warm water may be added for better results.
Side effectsView
This syrup is proven as safe. It is well tolerated. In high dose diarrhea, vomiting may occur.
ContraindicationsView
No report is available on contraindication. It may be happen in patients who are hypersensitive to any of its ingredients.
InteractionsView
No report is available.
Pregnancy & lactationView
The safety of this syrup in pregnancy has not been studied. Therefore, it should be used with caution during pregnancy.
StorageView
Keep out of reach of children. Keep away from direct sunlight. Store in a cool and dry place.
Remood
Flupentixol + Melitracen
Remood
Flupentixol + Melitracen
Indications
Psychosis
Indication detailsView
Flupentixol and Melitracen tablet is indicated in-
- Anxiety
- Depression
- Apathy
- Psychogenic depression.
- Depressive neurosses.
- Masked depression.
- Psychosomatic affections accompanied by anxiety and apathy.
- Menopausal depressions.
- Dysphoria and depression in alcoholics and drug addicts.
Therapeutic classView
Combined anxiolytics & anti-depressant drugs
PharmacologyView
This consists of two well known and well proven compounds: flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and melitracen-a bipolar thymoleptic with activating properties in low doses. In combination the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of flupentixol and in about 4 hours after oral administration of melitracen. The biological half-life of flupentixol is about 35 hours and that of melitracen is about 19 hours. The combination of flupentixol and melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.
DosageView
Adults: Usually 2 tablets orally daily in the morning and noon. In severe cases, the morning dose may be increased to 2 tablets.
Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
Elderly patients: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet orally in the morning. In cases of insomnia or severe restlessness, additional treatment with a sedative in the acute phase is recommended.
Side effectsView
In the recommended doses side effects are rare. These could be transient restlessness and insomnia.
ContraindicationsView
- The immediate recovery phase after myocardial infarction.
- Defects in bundle-branch conduction.
- Untreated narrow-angle glaucoma.
- Acute alcohol, barbiturate and opiate intoxications.
- This tablet should not be given to patients who have received an MAO-inhibitor within two weeks.
- Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
PrecautionsView
If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.
InteractionsView
This tablet may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.
Pregnancy & lactationView
This tablet should preferably not be given during pregnancy and lactation.
Overdose effectsView
In cases of overdosage the symptoms of intoxications by melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to flupentixol occur. Symptomatic and Supportive. Gastric lavage should be carried out as soon as possible and activated charcoal may be administered. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) must not be used for such patients. Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.
Remopain
Methyl Salicylate + Menthol + Camphor
Remopain
Methyl Salicylate + Menthol + Camphor
Indications
Strains
Indication detailsView
This cream is indicated for the fast relief of minor aches and pains of muscles and joints e.g., Simple Backache, Arthritis, Strains, Bruises and Sprains.
Therapeutic classView
Topical anti-inflammatory preparations
PharmacologyView
This cream is a specially formulated Methyl salicylate, Menthol and Camphor cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Methyl salicylate has been shown that first pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect. Camphor is a stimulant, used topically to increase local blood flow and as a 'counterirritant', which reduces pain & swelling. When in combination with other ingredients like menthol, methyl salicylate, it becomes ideal for neuralgia and other painful areas.
DosageView
Adults and children (12 years of age and older): Apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: Use on advice of a physician.
Children under 12 years of age: Use on advice of a physician.
Side effectsView
Redness or irritation may occur, especially in persons with sensitive skin.
ContraindicationsView
Hypersensitivity to salicylate or any of its ingredients.
PrecautionsView
For external use only. Do not use-
- on wounds or damaged skin
- with a heating pad
- on a child under 12 years of age with arthritis-like conditions.
InteractionsView
There are no known drug interactions and none well documented.
Pregnancy & lactationView
This medication should be used only if clearly needed during pregnancy or while breast-feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Remophos
Calcium Acetate
Remophos
Calcium Acetate
Indication detailsView
Calcium Acetate is indicated for the control of hyperphosphatemia in end stage renal disease (ESRD) and does not promote aluminum absorption.
PharmacologyView
Calcium Acetate when taken with meals, combines with dietary phosphate to form insoluble Calcium Phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium Acetate is highly soluble at neutral pH, making the Calcium readily available for binding to phosphate in the proximal small intestine. Orally administered Calcium Acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under non fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
DosageView
The recommended initial dose of Calcium Acetate for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate level below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3-4 tablets with each meal.
Pediatric Use: The safety and efficacy of Calcium Acetate have not been established.
Geriatric Use: In clinical studies, no overall differences in safety or effectiveness were observed between the geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Pediatric Use: The safety and efficacy of Calcium Acetate have not been established.
Geriatric Use: In clinical studies, no overall differences in safety or effectiveness were observed between the geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Side effectsView
Patients may occasionally experience nausea during Calcium Acetate therapy. Hypercalcemia may occur during treatment with Calcium Acetate. Mild hypercalcemia (Ca >10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca >12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the Calcium Acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium Acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium Acetate induced hypercalcemia. The long-term effect of Calcium Acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
ContraindicationsView
Calcium Acetate is contraindicated in patients with hypercalcemia.
PrecautionsView
Excessive dosage of Calcium Acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium Acetate should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium Acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia.
InteractionsView
Calcium Acetate may decrease the bioavailability of tetracycline.
Pregnancy & lactationView
Teratogenic Effects: Category C. Animal reproduction studies have not been conducted with Calcium Acetate. It is also not known whether Calcium Acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium Acetate should be given to a pregnant woman only if clearly needed.
Overdose effectsView
Administration of Calcium Acetate in excess of the appropriate daily dosage can cause severe hypercalcemia.
StorageView
Store at 15o C to 30o C in a dry place protected from light. Keep out of reach of children.