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This gel is indicated for the following scar treatment:

• hypertrophic and keloid scars
• scar that occurs after surgery
• scar that occurs after amputation, burns and trauma
• scar due to traumatic tendon contracture

Extract of Allium cepa: It is derived from the membrane of Allium cepa (onion membrane). It shows antiphlogistic efects through inhibition of infammatory mediators’ secretion and anti-allergenic efect. Extract of Allium cepa inhibits growth of fbroblast of diferent origin, particularly kelloidal fbroblasts. It has also bactericidal efect. While these properties stimulate primary wound healing, it prevents non-physiological scar formation.

Heparin: In case of local application, it shows inhibitory efect on fbroblast proliferation. While heparin increases tissue hydration, it reduces irritation resulted from induration and infammation.

Allantoin: Allantoin stimulates cellular proliferation. It also supports the development of healthy cells. Allantoin is convenient substance for the treatment of scar through its properties of stimulating epithelization and providing elastic surface formation.

Clinical studies:

• Evaluation of the use of Extract of Allium cepa, Heparin & Allantoin gel for the prevention of scar formation: Total 1,268 patients were evaluated and after 2 to 3 months of treatment with Extract of Allium cepa, Heparin & Allantoin gel, a reduction of 31.5% in mean scar width and 47.8% reduction of mean scar height at the end of the observation period.
• Assessment of the use of Extract of Allium cepa, Allantoin, and Heparin in the early treatment of C-section scars: A total of 61 females, aged ≥18 years, who had given birth by C-section were evaluated. After six weeks of treatment, the gel showed signifcant improvement of the color, stifness and irregularity of C-section scars.

This gel should be applied 3-4 times a day to the affected area and massaged gently in order to achieve better penetration. Continue with a circular motion until the gel is completely absorbed. Treatment may take several weeks or months depending on the size of existing scars and contracture.

This gel is very safe and its tolerability has been proven in numerous clinical studies. Small children and even babies can be treated safely.

This gel is generally well tolerated even in long-term use. In rare cases, some local irritations are reported such as slight erythema and itching. These side effects do not require discontinuation of the treatment.

This gel should not be used in patients with known hypersensitivity to any of its ingredients.

During treatment of fresh scars with this preparation, excess cold, UV lights and abrupt massage should be avoided. Avoid contact with eyes, the inside of the nose or mouth and other mucous membranes.

There is no known and reported drug interaction.

There are no studies conducted during pregnancy and lactation periods. Therefore it should be used with caution.

Store in a cool and dry place, below 25°C. Protect from direct sunlight and moisture. Do not freeze. Keep the medicine out of the reach of children.

Chlorpheniramine Maleate is indicated in the following indications-

• Urticaria
• Sensitivity reactions
• Angioneurotic edema
• Vasomotor rhinitis
• Cough
• Common cold
• Motion sickness and
• Other allergic conditions.

Sedating Anti-histamine

Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.

Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

Child-

• 6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
• 2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
• 1-2 years: 1 mg twice daily.

Below 1 year the use of Chlorpheniramine Maleate is not recommended.

Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.

Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.

Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.

Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.

This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.

Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

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.

Combined anxiolytics & anti-depressant drugs

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.

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.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

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.

This tablet should preferably not be given during pregnancy and lactation.

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.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

Chlorpheniramine Maleate is indicated in the following indications-

• Urticaria
• Sensitivity reactions
• Angioneurotic edema
• Vasomotor rhinitis
• Cough
• Common cold
• Motion sickness and
• Other allergic conditions.

Sedating Anti-histamine

Chlorpheniramine Maleate is an alkylamine antihistamine. It is one of the most potent histamine H1-receptor blocking agents which is used as a potent antihistamine. This generally causes less sedation than promethazine. Chlorpheniramine Maleate exerts its effects by blocking H1-receptor competitively.

Adult- Usual adult dose is 4 mg every 4-6 hours, maximum 24 mg daily.

Child-

• 6-12 years: 2 mg every 4-6 hours, maximum 12 mg daily.
• 2-5 years: 1 mg every 4-6 hours, maximum 6 mg daily.
• 1-2 years: 1 mg twice daily.

Below 1 year the use of Chlorpheniramine Maleate is not recommended.

Chlorpheniramine is well-tolerated, but sometimes drowsiness, dizziness, muscular weakness, and gastrointestinal upset may occur.

Chlorpheniramine is contraindicated in patients hypersensitive to this agent, in newborn or premature infants.

Chlorpheniramine should be used with caution in patients with glaucoma and prostatic hypertrophy. During therapy with chlorpheniramine, caution should be taken in driving vehicles and operating machinery.

Chlorphenamine maleate has been reported to be incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate, pentobarbital sodium, and meglumine adipiodone.

This drug should not be used in lactating mother and in pregnancy especially during the first trimester of pregnancy.

CNS depression (including sedation, apnea, CV collapse), CNS stimulation (including insomnia, hallucination, tremors, convulsions), tinnitus, blurred vision, dizziness, ataxia, hypotension. Stimulation and atropine-like signs and symptoms (including dry mouth, fixed dilated pupils, flushing, hyperthermia, Gl symptoms) are more likely in children.

Store in a cool (Below 25°C temperature) and dry place protected from light. Keep out of the reach of children.

Adefovir Dipivoxil is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Hepatic viral infections (Hepatitis B)

Adefovir dipivoxil is a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV). Adefovir is phosphorylated to the active metabolite, adefovir diphosphate, by cellular kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA. The approximate oral bioavailability of adefovir from a 10 mg single dose is 59%. In vitro binding of adefovir to human plasma or human serum proteins is 4%. Adefovir is excreted through renal route by a combination of glomerular filtration and active tubular secretion.

The recommended dose of Adefovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food.

The most common side effects of adefovir dipivoxil are weakness, headache, stomach pain and nausea. Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with adefovir dipivoxil. In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir dipivoxil may result in nephrotoxicity. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.

Adefovir dipivoxil is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.

Patients who discontinued adefovir dipivoxil should be monitored at repeated intervals over a period of time for hepatic function. The patients at risk of or having underlying renal dysfunction should be monitored closely for renal function and may require dose adjustment.

The pharmacokinetics of adefovir was unchanged when adefovir dipivoxil was coadministered with lamivudine, trimethoprim/ sulfamethoxazole and acetaminophen. When adefovir dipivoxil was co-administered with ibuprofen (800 mg three times daily), increases in adefovir Cmax (33%), AUC (23%) and urinary recovery were observed due to higher oral bioavailability of adefovir.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Adefovir dipivoxil should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. It is not known whether adefovir is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking adefovir dipivoxil.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Geriatric use: In general, caution should be exercised when prescribing to elderly patients since they have greater frequency of decreased renal or cardiac function due to concomitant disease or other drug therapy.

Dose Adjustment in Renal Impairment: the dosing interval of Adefovir should be adjusted in patients with baseline creatinine clearance <50 ml/min using the following suggested guidelines:

• CrCl ≤ 50 ml/min: 10 mg
• CrCl 20-49 ml/min: 10 mg every 48 hours
• CrCl 10-19 ml/min: 10 mg every 72 hours
• Haemodialysis patients: 10 mg every 7 days following dialysis

Doses of adefovir dipivoxil 500 mg daily for 2 weeks and 250 mg daily for 12 weeks have been associated with gastrointestinal side effects. If overdose occurs the patient must be monitored for evidence of toxicity and standard supportive treatment applied as necessary.

Store at cool and dry place. Protect from light and moisture. Keep all the medicines out of the reach of children.

Vaccines, Anti-sera & Immunoglobulin

Snake venom antiserum is a sterile preparation containing antitoxin globulins and their derivatives. It is the only specific treatment for venomous snake bites.

As of now Snake venom antiserum is the only specific antidote for snake envenomation and prompt administration of adequate dose of Antiserum is of paramount importance for neutralization of unbound circulating snake venom components for early response to treatment. Any delay in administration may result in increased dose requirement and decreased effectiveness. As the clinical signs can vary due to many factors such as type of snake, time of reporting after bite, size of snake, amount of venom injected during bite, seasonal & regional variation in venom composition etc., no accurate dosage can be recommended.

However, considering the average quantity of venom injected by snake at the time of bite and degree of envenomation, it is recommended to administer initial dose of 5-10 vials of Snake venom antiserum by slow intravenous infusion either undiluted at a speed of not more than 2 ml per minute or after dilution with Normal /glucose saline at a rate of 5-10 ml/kg body weight over one hour. Children should receive the same dose as adults. Constant monitoring of the vital signs at frequent intervals during initial 1 hour is recommended. Requirement of further dosing depends on extent of reversal of coagulopathy confirmed after 6 hours of Antiserum administration by WBCT in haemotoxic bite or if symptoms persist or worsen or in respiratory failure in neurotoxic bite after 1 hour of Antiserum administration.

If the blood is still in coagulable or no signs of reversal of paralysis are seen, a further dose of 5 to 10 vials of Antiserum should be administered by slow IV route only. Administration by IM or locally around the bite wound is not recommended. In the majority of cases of both neurotoxic and haemotoxic bites, total dose of 15-20 vials is adequate unless a proven recurrence of envenomation is established. In such a scenario, further doses can be given as per clinical condition of the patient. Hypersensitivity skin test has no predictability value and hence should not be used.

Snake venom antiserum being derived from equines is heterologous to human can give either early or late reaction. Adrenaline should be always kept handy, before starting the dose of Snake venom antiserum. Reduction in adverse reactions has been reported by use of adequate dilution of Snake venom antiserum with saline and controlling rate of infusion.

There are no known contraindications for the administration of Snake venom antiserum. Proper precautions are necessary while dealing with persons with a known hypersensitivity to constituents of product. Few doctors prefer to premedicate patients with Inj. Adrenaline 0.25 ml s/c to prevent possibility of adverse reactions. In haemotoxic bites, IM injections should be avoided till correction of coagulopathy to avoid formation of haematoma and oozing of blood. In patients having tourniquet, it should be released slowly only after start of Snake venom antiserum administration.

Proper skin test should be done prior to parenteral admin of the antivenom to identify risk of anaphylaxis.

Risk of increased severity of acute anaphylaxis when used with β-adrenergic blockers.

Considering the risk associated with snake bite envenomation, pregnancy is not a contraindication for the administration of Snake Venom Antiserum subsequent to bite.

To reconstitute the Snake Venom Antiserum, transfer content of supplied diluents into the vial containing lyophilized preparation. Mix the contents gently by swirling action and avoid vigorous shaking. Serum should be used as soon as possible after reconstitution.

Lyophilized Snake venom antiserum is stable at room temperature and does not require special storage facilities. Ideally, it should be stored in a cool & dark place and do not expose to excessive heat.

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants

Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.

Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.

Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.

CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.

Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Apixaban can cause a skin rash or severe allergic reaction.

Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).

Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.

Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.

Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment

Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.

There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics), Oral Anti-coagulants

Apixaban acts by inhibiting coagulation, and thus prevents development of blood clots. As a result of FXa inhibition, apixaban prolongs clotting tests such as prothrombin time (PT), INR, and activated partial thromboplastin time (aPTT). Changes observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.

Recommended Dose: The recommended dose of Apixaban for most patients is 5 mg taken orally twice daily.

Dosage Adjustments: The recommended dose of Apixaban is 2.5 mg twice daily in patients with any 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, serum creatinine ≥1.5mg/dl.

CYP3A4 and P-gp inhibitors: When Apixaban is coadministered with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) the recommended dose is 2.5 mg twice daily.

Missed Dose: If a dose of Apixaban is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Discontinuation for Surgery and Other Interventions: Apixaban should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. Apixaban should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled.

Switching from or to Apixaban: Switching from warfarin to Apixaban: Warfarin should be discontinued and Apixaban started when the international normalized ratio (INR) is below 2.0.

Switching from Apixaban to warfarin: Apixaban affects INR, so that INR measurements during co-administration with warfarin may not be useful for determining the appropriate dose of warfarin. If continuous anticoagulation is necessary, discontinue Apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of Apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching between Apixaban and anticoagulants other than warfarin: Discontinue one being taken and begin the other at the next scheduled dose.

Apixaban can cause a skin rash or severe allergic reaction.

Apixaban is contraindicated in patients with the following conditions: Active pathological bleeding. Severe hypersensitivity reaction to Apixaban (i.e. anaphylactic reactions).

Increased Risk of Stroke with Discontinuation of Apixaban Discontinuing Apixaban in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from Apixaban to warfarin in clinical trials in patients with nonvalvular atrial fibrillation. If Apixaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.

Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to Apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to Apixaban and increase the risk of stroke.

Pregnancy: There are no adequate and well-controlled studies of Apixaban in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. Apixaban should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.

Labor and Delivery: Safety and effectiveness of Apixaban during labor and delivery have not been studied in clinical trials. Consider the risks of bleeding and of stroke in using Apixaban in this condition.

Nursing Mothers: It is unknown whether Apixaban or its metabolites are excreted in human milk. Women should be instructed either to discontinue breastfeeding or to discontinue Apixaban therapy, taking into account the importance of the drug to the mother.

Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. Because patients with moderate hepatic impairment may have intrinsic coagulation abnormalities and there is limited clinical experience with Apixaban in these patients, dosing recommendations cannot be provided Apixaban is not recommended in patients with severe hepatic impairment

Renal Impairment: The dosing adjustment for moderate renal impairment is described above. No data inform use in patients with creatinine clearance <15 ml/min or on dialysis.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Of the total subjects in clinical studies of Apixaban, >69% were 65 and older, and >31% were 75 and older. The effects of Apixaban on the risk of stroke and major bleeding compared to warfarin were maintained in geriatric subjects.

There is no antidote to Apixaban. Overdose of Apixaban increases the risk of bleeding. Activated charcoal may be useful in the management of Apixaban overdose.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Other Anti-anginal & Anti-ischaemic drugs

Ranolazine has anti-ischemlc and antlanginal effects that do not depend upon reductions in heart rate or blood pressure.The exact mechanism of action of ranolazine is unknown. Ranolazine at therapeutic levels can inhibit the cardiac late sodium current (I_Na). However, the relationship of this inhibition to angina symptoms is uncertain.

The QT prolongation effect of ranolazine on the surface electrocardiogram is the result of inhibition of I_Kr which prolongs the ventricular action potential.

Initiate Ranolazine dosing at 500 mg twice daily and increase to 1000 mg twice daily, if needed, based on clinical symptoms. Take Ranolazine with or without meals. Swallow Ranolazine tablets whole; do not crush, break or chew. The maximum recommended daily dose of Ranolazine is 1000 mg twice daily. If a dose of Ranolazine is missed, take the prescribed dose at the next scheduled time; do not double the next dose.

Cardiac Disorders: bradycardia, palpitations
Ear and Labyrinth Disorders: tinnitus, vertigo
Gastrointestinal Disorders: abdominal pain, dry mouth, vomiting
General Disorders and Administrative Site Adverse Events: peripheral edema
Respiratory, Thoracic, and Mediastinal Disorders: dyspnea
Vascular Disorders: hypotension, orthostatic hypotension

Ranolazine is contraindicated in patients:

• With pre-existing QT prolongation
• With hepatic impairment
• Taking QT prolonging drugs
• Taking potent and moderately potent CYP3A inhibitors such as ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, including diltiazem.

Ranolazine blocks QTc and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death.

Co-administration of ranolazine with digoxin increases the plasma concentrations of digoxin by approximately 1.5-fold and the dose of digoxin may have to be reduced accordingly. The dose of other P-gp substrates may have to be reduced as well when ranolazine Is co-admlnistered. Caution should be exercised when co-adminlstering ranolazine with P-gp inhibitors such as ritonavir or cydosporine.

CYP 3A Inhibitors: Do not use Ranolazine with strong CYP 3A inhibitors. With moderate CYP 3A inhibitors (e.g., diltiazem, verapamil, erythromycin) limit maximum dose of ranolazine to 500 mg twice daily.

CYP 3A Inducers: Do not use Ranolazine with inducers.

P-gp Inhibitors (e.g., Cyclosporin): May need to lower the Ranolazine dose based on clinical dose.

Drugs transported by P-gp or metabolized by CYP2D6 (eg., digoxin, TCA): May need reduced doses of these drugs when used with ranolazine.

Pregnancy Category C. There are no adequate studies assessing the effect of ranolazine on the developing fetus. There are no adequate well-controlled studies in pregnant women. Ranolazine should be used during pregnancy only when the potential benefit to the patient justifies the potential risk to the fetus.lt is not known whether ranolazine is excreted in human milk. Because of the potentiality for serious adverse reactions from ranolazine in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Ranolazine, taking into account the importance of the drug to the mother.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Renal Impairment:

• Mild to moderate (CrCl 30-80 mL/min): Dose titration needed
• Severe (CrCl <30 mL/min): Contraindicated

Hepatic Impairment:

• Mild: Dose titration needed
• Moderate to severe: Contraindicated

Symptoms: Dizziness, nausea, vomiting, diplopia, lethargy, syncope, severe tremor, incoordination, dysplasia, hallucination.

Management: Symptomatic and supportive treatment.

Store Ranolazine tablets at 25°C with excursion permitted to 15° to 30°C. Protect from light and moisture.

Trimetazidine Dihydrochloride is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.

Other Anti-anginal & Anti-ischaemic drugs

Trimetazidine Dihydrochloride is the first 3- keto acyl CoA thiolase inhibitor (KAT), a metabolic anti-ischemic agent with proven benefits for all coronary patients. Trimetazidine Dihydrochloride inhibits fatty acid pathway by inhibiting 3-keto acyl CoA thiolase enzyme and transfers oxygen to glucose pathway. Since glucose pathway is more efficient in producing energy, the same oxygen produces more energy and makes the heart more active. Moreover, the aerobic oxidation of glucose stops production of lactic acid, which prevents angina pectoris.

The recommended dose of Trimetazidine is 35 mg twice daily or 20 mg tablet thrice daily during meals. The benefit of the treatment should be assessed after three months and Trimetazidine should be discontinued if there is no treatment response.

Trimetazidine is safe and well tolerated. The Common side effects associated with Trimetazidine are dizziness, headache, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, rash, pruritus, urticaria and asthenia

Trimetazidine is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also is contraindicated in patients with Parkinson’s disease, parkinsonian symptoms, tremors, restless legs movement disorders, severe renal impairment.

Trimetazidine is not a curative treatment for angina attacks, nor an initial treatment for unstable angina pectoris. It is also not a treatment for myocardial infarction.

No drug interaction so far has been reported. In particular, no interaction has been reported with beta-blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation.

There is no data on the use of Trimetazidine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Trimetazidine during pregnancy. It is unknown whether Trimetazidine is excreted in human milk. A risk to the newborns/infants cannot be excluded. Trimetazidine should not be used during breast-feeding.

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

Anti-oxidant Multivitamin preparations

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Carocet is contraindicated in patients with hypersensitivity to any of its components.

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Should be stored in a dry place below 30˚C.

Oxyphenonium is indicated in Gastro-intestinal spasm and hypermotility, cardiospasm, esophagospasm, gastroduodenitis, spastic constipation, pylorospasm, peptic ulcer, spasm associated with carcinoma. Pain and spasm of the biliary tract. Pain and spasm of the urinary tract.

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Oxyphenonium is an anticholinergic drug, a medication that reduces the effect of acetylcholine, a chemical released from nerves that stimulates muscles, by blocking the receptors for acetylcholine on smooth muscle (a type of muscle). It also has a direct relaxing effect on smooth muscle. Oxyphenonium is used to treat or prevent spasm in the muscles of the gastrointestinal tract in the irritable bowel syndrome. In addition, Oxyphenonium inhibits gastrointestinal propulsive motility and decreases gastric acid secretion and controls excessive pharyngeal, tracheal and bronchial secretions.

Average adult dosage is 10 mg (2 tablets) 4 times daily for several days. Dosage may be reduced depending on patient's response or as directed by the physician.

Common side effects are dryness of mouth, headache, palpitations, etc.

Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prospective hypertrophy), obstructive disease of the gastrointestinal tract (as in achalasia, paralytic ileus, pyloroduodenal stenosis, etc.), intestinal atony of the elderly or debilitated patient, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, complicating ulcerative colitis, myasthenia gravis, hypersensitivity.

Children; elderly; benign prostatic hyperplasia; acute MI, cardiac failure, hypertension, thyrotoxicosis; pregnancy and lactation; fever; angle-closure glaucoma.

Reduced gastric motility interferes with absorption of other drugs. Effects potentiated by other antimuscarinics including amantadine, some antihistamines, phenothiazines and TCA.

Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Treatment is the same as for atropine overdosage.

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

Oxyphenonium is indicated in Gastro-intestinal spasm and hypermotility, cardiospasm, esophagospasm, gastroduodenitis, spastic constipation, pylorospasm, peptic ulcer, spasm associated with carcinoma. Pain and spasm of the biliary tract. Pain and spasm of the urinary tract.

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Oxyphenonium is an anticholinergic drug, a medication that reduces the effect of acetylcholine, a chemical released from nerves that stimulates muscles, by blocking the receptors for acetylcholine on smooth muscle (a type of muscle). It also has a direct relaxing effect on smooth muscle. Oxyphenonium is used to treat or prevent spasm in the muscles of the gastrointestinal tract in the irritable bowel syndrome. In addition, Oxyphenonium inhibits gastrointestinal propulsive motility and decreases gastric acid secretion and controls excessive pharyngeal, tracheal and bronchial secretions.

Average adult dosage is 10 mg (2 tablets) 4 times daily for several days. Dosage may be reduced depending on patient's response or as directed by the physician.

Common side effects are dryness of mouth, headache, palpitations, etc.

Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prospective hypertrophy), obstructive disease of the gastrointestinal tract (as in achalasia, paralytic ileus, pyloroduodenal stenosis, etc.), intestinal atony of the elderly or debilitated patient, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, complicating ulcerative colitis, myasthenia gravis, hypersensitivity.

Children; elderly; benign prostatic hyperplasia; acute MI, cardiac failure, hypertension, thyrotoxicosis; pregnancy and lactation; fever; angle-closure glaucoma.

Reduced gastric motility interferes with absorption of other drugs. Effects potentiated by other antimuscarinics including amantadine, some antihistamines, phenothiazines and TCA.

Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Treatment is the same as for atropine overdosage.

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

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Sedating Anti-histamine

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

The most common side effects that occurred more frequently on Cetirizine is somnolence.

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

Caution should be exercised when driving a car or operating a heavy machinery.

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

US FDA Pregnancy Category of Cetirizine Hydrochloride 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. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

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

This syrup is indicated for the relief of cough, associated congestive symptoms and aiding restful sleep

Combined cough expectorants

Guaifenesin is reported to reduce the viscosity of tenacious sputum end is used as an expectorant. Levomenthol has mild local anesthetic and decongestant properties. Diphenhydramine Hydrochloride possesses antitussive, antihistaminic, and anticholinergic properties.

For adults and children over 12 years: 2 teaspoonfuls syrup 4 times a day or as directed by the physicians. Do not take more than 8 teaspoonful syrup in 24 hours.

Use in Children & Adolescents: The efficacy and safety of Guaifenesin have not been established in pediatric patients and adolescents.

This syrup may cause drowsiness, dizziness, nausea and vomiting, gastro-intestinal disturbance, dry mouth, nose and throat difficulty in urination or blurred vision.

This syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine should not be administered to patients who have received treatment with MAOIs within last two weeks.

This syrup may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine Hydrochloride should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions unless directed by a physician.

This syrup contains Diphenhydramine Hydrochloride and therefore may potentiate the effects of alcohol, and other CNS depressants. As Diphenhydramine Hydrochloride possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.

As with any other medicine, care should be taken In administration during pregnancy. This product has not been associated with adverse effects in the human fetus or suckling infant.

When taken in excess, Guaifenesin may cause renal calculi. Treatment of overdose should be symptomatic and supportive.

Store at a temperature not exceeding 30° C in a dry place. Protect from light & moisture. Keep out of the reach of children.

This is indicated for-

• Internal and external hemorrhoids
• Post-partum hemorrhoidal condition
• Anal pruritus, peri-anal eczema, anal fissures and proctitis 
• Post-hemorrhoidectomy application to relieve pain and discomfort

Compound steroidal preparations, Drugs used in Ano-rectal region

Cinchocaine is a local anesthetic which relieves severe pain and relaxes sphincteric spasm. Hydrocortisone acts as an anti-inflammatory and anti-pruritic agent and thereby eliminates itching and inflammation. Neomycin is a broad-spectrum antibiotic which eradicates most infections which may already be present or arise in lesions of the anorectal area. Esculin improves skin vasculature and is effective in management of cellulitis.

Ointment: A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and should be squeezed gently from the lower end while withdrawing.

Suppository: One suppository in the morning and one in the evening, and one after each stool.

Use in children: Not recommended for children.

Side effects which have been reported for individual constituents may occur and appropriate precautions should be taken when using this preparation.

Contraindicated in patients hypersensitive to any component of the product.

Like most of the steroids under certain circumstances hydrocortisone may be absorbed in sufficient amount to produce systemic effects. So, long term use should be avoided. Adrenal suppression may occur even without occlusion. When used for prolonged period striae may occur. Skin sensitisation may occur due to Neomycin. Absorption of the antibiotic from wound or inflamed skin may occur and this may affect the hearing irreversibly. Hence this preparation should not be given to extensively damaged skin.

Use in pregnancy: The safe use of topical corticosteroids during pregnancy has not been fully established.

Keep in a cool dry place protected from light. Keep out of reach of children.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

The mechanism of action of Diclofenac Potassium, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Adults: Following an initial loading dose of 50 mg, 25-50 mg is to be taken every eight hours if necessary.

Migraine: An initial loading dose of 50 mg, then if necessary a further 25-50 mg after 2 hours. The maximum daily dose is 150 mg. The tablets should be swallowed whole with liquid, preferably before meals.

Children: Children over 14 years of age: upto 75 mg daily in divided doses.

Side-effects of Diclofenac are usually mild and transient. However, if serious side-effects occur. Diclofenac should be discontinued. Occasional: epigastric pain, other gastro-intestinal disorders (e.g., nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia,flatulence,anorexia). Rare: gastro-intestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea.

Diclofenac Potassium tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac should not be given to patients who have experienced asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients. Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Diclofenac may have the following drug interactions:

• Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.
• Anticoagulant:There are isolated reports of and increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy.
• Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.
• Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.
• Diuretics: Like other NSAIDs, Diclofenac may inhibit the activity of diuretics.
• Other NSAIDs and steroids; Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects.

Diclofenac should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drugs are not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.

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

Prevention and treatment of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of the vestibular system (e.g. Meniere's syndrome, labyrinthitis and other vestibular disturbances).

Anti-emetic drugs

Meclizine is a piperazine-derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It reduces the sensitivity of the labyrinthine apparatus. The action may be mediated through nerve pathways to the vomiting center (VC) from the chemoreceptor trigger zone (CTZ), peripheral nerve pathways, the VC, or other CNS centers. Pyridoxine is vitamin B-6. It has been added to enhance the anti-emetic effects & as a dietary suppliment.

Adult and Children 12 years of age & over:

• Nausea and vomiting: 25-50 mg daily or as directed by a physician.
• Motion sickness: Take an initial dose of 25-50 mg, 1 hour prior to travel. May repeat the dose every 24 hours for the duration of the journey.
• Radiation sickness: 50 mg administered 2-12 hours prior to radiation treatment.
• Vertigo: 25-100 mg daily in divided doses.
• Prevention of nausea and vomiting associated with emergency contraceptive pill (ECP): 25-50 mg, 1 hour before first ECP dose; repeat if needed in 24 hours.

The safety and efficacy for use in children less than 12 years of age have not been established.

Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.

Meclizine Hydrochloride and Pyridoxine Hydrochloride is contraindicated in patients who are hypersensitive to these ingredients.

Patients should be warned that Meclizine Hydrochloride may impair their ability to perform hazardous activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle). Patients should avoid alcoholic beverages while taking this drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.

The CNS depressant effects of Meclizine can be potentiated by concurrent use of Ethanol or other CNS depressant agents such as Benzodiazepines, Barbiturates, Tricyclic antidepressants, opiate agonists, skeletal muscle relaxants and antihistamines. Concurrent use of other anticholinergics can potentiate the anticholinergic effects of Meclizine. Meclizine can increase the absorption of digoxin by decreasing gastrointestinal motility.

Pregnancy Category B. Large-scale human studies have not demonstrated adverse fetal effects. It has been suggested that based on available data, Meclizine presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy. Safety for use in the nursing mother has not been established.

Symptoms: Extreme excitability, seizures, drowsiness and hallucinations.
Treatment: Appropriate supportive and symptomatic treatment. Consider dialysis

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

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.

Combined anxiolytics & anti-depressant drugs

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.

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.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

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.

This tablet should preferably not be given during pregnancy and lactation.

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.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.

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.

Combined anxiolytics & anti-depressant drugs

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.

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.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

If previously the patient has been treated with tranquillizers with sedative effect these should be withdrawn gradually.

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.

This tablet should preferably not be given during pregnancy and lactation.

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.

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.