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This hand sanitizer is generally used to decrease infectious agents on the hands and is the most commonly used disinfectant in pharmaceutical industries. The important thing is that only 70% solution of isopropyl alcohol acts as a disinfectant killing all surface microorganisms. It is used to disinfect hands and equipment surface in pharmaceuticals.

Bleaching and Disinfectants

Isopropyl Alcohol is an isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic. 70 % isopropyl alcohol solution kills microorganisms by dissolving plasma membrane of the cell wall.

Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.

Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.

Alcohol-based hand sanitizer is more convenient compared to hand washing with soap and water in most situations in the healthcare setting. It is generally more effective at killing microorganisms and better tolerated than soap and water. Alcohol-based hand sanitizer is recommended only if soap and water are not available. Using guideline is given bellow-

1. Apply product to the palm of one hand.
2. Rub hands together.
3. Rub the product over all surfaces of hands and fingers until hands are dry.

Inhaling large amounts of isopropyl alcohol can cause nausea, vomiting, irritation of the nose and mucous membranes, throat irritations, and even difficulty with breathing as coughing can occur making it difficult for you to catch your breath. Isopropyl alcohol may cause burning, stinging, or a cold feeling where the medicine is applied.

Isopropyl Alcohol is contraindicated in patients with known Hypersensitivity.

Isopropyl Alcohol is highly flammable in the presence of heat, sparks, or an open flame. When handling isopropyl alcohol in a work environment (to best to avoid any contact with skin) protective clothing should be always be worn, including safety gloves and goggles. Isopropyl alcohol should be kept away from heat, sparks, flames and other sources of ignition, as well as strong oxidizers, acetaldehyde, chlorine, ethylene oxide, acids, and isocyanates. A flammable safety cabinet is the best storage option.

Isopropyl alcohol should be stored in a tightly closed container in a cool & dry place, protected from light, well-ventilated area. Due to the chemical's extreme flammability, it must be kept away from all possible ignition sources, including heat, sparks, and flames. Keep out of reach of children.

They are liquids used primarily as a topical antiseptic. They also have multiple industrial and household uses. The term "rubbing alcohol" has become a general non-specific term for either isopropyl alcohol (isopropanol) or ethyl alcohol (ethanol) rubbing-alcohol products.

Bleaching and Disinfectants

Ethanol and isopropyl alcohol are both members of the alcohol family and have similar disinfectant properties. Ethanol is the type of alcohol present in alcoholic beverages. Isopropyl alcohol is also known as isopropanol, 2-propanol or rubbing alcohol. When used as disinfectants, both are typically at a concentration of 70 percent in water.

শিশুদের নাগােলর বাইের রাখুন ।

আলো ও তাপ থেকে দূরে, ঘরের স্বাভাবিক তপমাত্রায় রাখুন

Iodine compounds (Anti-septic Preparations)

Povidone Iodine is a complex of iodine and an organic polymer, povidone. This polymerization makes Povidone Iodine superior to ordinary elemental iodine. It prolongs the germicidal activity of iodine by liberating elemental iodine slowly. Consequently it has a lower toxicity than elemental iodine. It gives rapid microbicidal activity against both Gram-positive and Gram-negative bacteria, protozoa, viruses and fungi/yeasts. It is also sporicidal. It is the only microbicide with this broad spectrum of activity. It is non-staining, exerts prolong germicidal action and is also active in the presence of soap, blood, serum, pus, mucosal secretions and water.

Cream or ointment:

• For the treatment of infection: Apply once or twice daily or at dressing changes for a maximum of 14 days.
• For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried and can be covered with a dressing or bandage.

Solution: Apply full strength as often as needed as paint, spray, or wet soak. Maybe bandaged (where necessary).

Gargle & Mouthwash: Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10 mL for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as advised by the Registered Dental Surgeon/Physician.

Surgical Scrub:

• For Preoperative and Postoperative washing by Operating Personnel: Wet hands and forearms with water. Pour about 5 mL of Povidone Iodine Surgical Scrub on the palm of the hand and spread over both hands and forearms. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use a brush if desired. Clean thoroughly under fingernails. Add a little water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 mL of Povidone Iodine Surgical Scrub in the same way.
• For Preoperative use on Patients: After the skin area is shaved, wet it with water. Apply Povidone Iodine Surgical Scrub (1 mL is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water.
• For use in the Physician's Office: Use for washing whenever a germicidal soap is required.

Powder: Apply a light dusting of powder to the affected area. When dry, this forms a protective antiseptic layer over the area treated. Or use as advised by the Registered Physician. There are no special dosage recommendations for children or elderly patients.

Ophthalmic Solution: 1 drop 4 times daily or as required, depending upon the severity of the disease, to be instilled into the conjunctival sac.

Povidone Iodine may cause hypersensitivity reactions and irritation of the skin and mucous membranes. The application of povidone Iodine to severe burns or to large areas otherwise denuded of skin may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. It may interfere with thyroid function tests.

It can cause hypersensitivity reactions. Regular use in patients with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis) or those receiving lithium therapy is to be avoided. In severely burnt patients serum iodide levels should be assessed due to possible hepatic and renal impairment. Povidone Iodine Powder should not be used in serious cavities and in Children under the age of 2 years.

Cream or ointment: In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Solution: In preoperative prepping, avoid 'pooling' beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. In case of deep or puncture wounds or serious burns, consult Registered Physician. If redness, irritation, swelling or pain persists or increases or if infection occurs, discontinue use and consult Registered Physician.

Gargle & Mouthwash: Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days seek dental or medical advice. It is also not for use in children under 6 years of age. Regular use should be avoided in patients on concurrent lithium therapy.

Surgical Scrub: Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy. It can permanently discolor white gold jewellery and it is recommended that this type of jewellery should be removed before using this product.

Powder: Care must be taken when used on known iodine sensitivity, although do not normally react to Povidone-Iodine. Excess powder can be washed off readily with warm water. It should be used directly from the container. Not to be administered internally.

Ophthalmic Solution: Patients, who experience blurred vision after application of the eye drops, should not drive or use machinery until their vision has cleared. Contact lenses should not be worn during the instillation of the drug. After instillation, there should be an interval of at least 30 minutes before reinsertion.

It exhibits interaction with strong alkali, sodium thiosulphate, sodium metabisulphite and thiomersal. Use with concurrent lithium therapy has been shown to exhibithypothyroidic effect.

Povidone Iodine Cream, Solution & Powder are not recommended for use during pregnancy because of the possibility of absorption of sufficient iodine to affect the fetal thyroid. American Academy of Pediatrics considers that the use of Povidone-Iodine is usually compatible with breast feeding. Consult Registered Physician. Regular use of Gargle & Mouthwash and Surgical Scrub should also be avoided in pregnant and lactating women.

There is no experience regarding the safety of the Povidone eye drops in human pregnancy or lactation. Administration during pregnancy and lactation is therefore not recommended, except for compelling reasons.

Store below 25°C. Do not freeze. Store in a cool and dry place, protected from light. Keep out of the reach of children. Do not touch the ophthalmic solution dropper tip to any surface as this may contaminate this preparation. Do not use it after one month of the first opening.

For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures

Chlorhexidine & Chloroxylenol preparations

Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.

Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.

Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.

Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.

Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare

Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.

Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.

Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.

No untoward effects are known

Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.

Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.

Do not store above 25° C.

This hand sanitizer is generally used to decrease infectious agents on the hands and is the most commonly used disinfectant in pharmaceutical industries. The important thing is that only 70% solution of isopropyl alcohol acts as a disinfectant killing all surface microorganisms. It is used to disinfect hands and equipment surface in pharmaceuticals.

Bleaching and Disinfectants

Isopropyl Alcohol is an isomer of propyl alcohol with antibacterial properties. Although the exact mechanism of isopropanol's disinfecting action is not known, it might kill cells by denaturing cell proteins and DNA, interfering with cellular metabolism, and dissolving cell lipo-protein membranes. Isopropanol is used in soaps and lotions as an antiseptic. 70 % isopropyl alcohol solution kills microorganisms by dissolving plasma membrane of the cell wall.

Glycerol: used as humectant, but other emollients may be used for skin care, provided that they are cheap, widely available and miscible in water and alcohol and do not add to toxicity, or promote allergy.

Hydrogen peroxide: used to inactivate contaminating bacterial spores in the solution and is not an active substance for hand antisepsis.

Alcohol-based hand sanitizer is more convenient compared to hand washing with soap and water in most situations in the healthcare setting. It is generally more effective at killing microorganisms and better tolerated than soap and water. Alcohol-based hand sanitizer is recommended only if soap and water are not available. Using guideline is given bellow-

1. Apply product to the palm of one hand.
2. Rub hands together.
3. Rub the product over all surfaces of hands and fingers until hands are dry.

Inhaling large amounts of isopropyl alcohol can cause nausea, vomiting, irritation of the nose and mucous membranes, throat irritations, and even difficulty with breathing as coughing can occur making it difficult for you to catch your breath. Isopropyl alcohol may cause burning, stinging, or a cold feeling where the medicine is applied.

Isopropyl Alcohol is contraindicated in patients with known Hypersensitivity.

Isopropyl Alcohol is highly flammable in the presence of heat, sparks, or an open flame. When handling isopropyl alcohol in a work environment (to best to avoid any contact with skin) protective clothing should be always be worn, including safety gloves and goggles. Isopropyl alcohol should be kept away from heat, sparks, flames and other sources of ignition, as well as strong oxidizers, acetaldehyde, chlorine, ethylene oxide, acids, and isocyanates. A flammable safety cabinet is the best storage option.

Isopropyl alcohol should be stored in a tightly closed container in a cool & dry place, protected from light, well-ventilated area. Due to the chemical's extreme flammability, it must be kept away from all possible ignition sources, including heat, sparks, and flames. Keep out of reach of children.

Clove oil is indicated in Bad breath (Halitosis), Tooth decay, Oral thrush, Dental pain, Inflammation of the mouth and pharynx.

Oral preparations

Clove oil is a herbal medicine which main ingredient is clove oil. It contains a large amount of eugenol that is commonly used in the treatment of oral infections and inflammation of the mucous membranes of the mouth and throat. Clove oil is effective, safe and well tolerated for all age groups

Adult: Should be taken 5 ml Clove oil with 10 ml-15 ml water and gurgle for 30 seconds of morning & bedtime daily.

Children: Should be taken 2.5 ml Clove oil with 10 ml water and gurgle for 30 seconds of morning & bedtime daily. Also undiluted clove oil is used in temporary relief of toothache due to dental cavity. Repeat administration after 20 minutes, then every 2 hours thereafter if necessary.

In concentrated form oil of clove may be irritating to mucosal tissues.

There are no known problems with the use of Clove oil during pregnancy and lactation.

Store below 30°C. temperature & dry place, protected from light. Keep all medicines out of reach of children.

Bad breath, Cavities, Gingivitis, Gum disease, Oral hygiene, Plaque, Teeth cleaner & brighter

Oral preparations

This preparation is a clinically proven antiseptic mouthwash that provides you complete care for healthier mouth with around-the-clock protection against bacteria and plaque. Your mouth stays cleaner, fresher and healthier.

• 24 hours protection against plaque, gingivitis and gum disease
• Fights against germs that cause bad breath
• Kills germs between teeth and keeps teeth cleaner & brighter

Rinse with 20 ml Antiseptic Mouthwash for 30 seconds, twice daily (morning and evening). Then rinse with water. Do not swallow. Not indicated below 12 years of age.

Do not rinse, eat, or smoke for thirty minutes after using a mouthwash. Doing so will diminish the effects of the mouthwash.

Hypersensitivity

Do not swallow. It is not indicated below 12 years of age. Keep out of the reach of children. Keep in a cool and dry palace. Do not use if cap seal is broken.

There are no known drug interactions and none well documented.

Pregnancy Category - Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Bad breath, Cavities, Gingivitis, Gum disease, Oral hygiene, Plaque, Teeth cleaner & brighter

Oral preparations

This preparation is a clinically proven antiseptic mouthwash that provides you complete care for healthier mouth with around-the-clock protection against bacteria and plaque. Your mouth stays cleaner, fresher and healthier.

• 24 hours protection against plaque, gingivitis and gum disease
• Fights against germs that cause bad breath
• Kills germs between teeth and keeps teeth cleaner & brighter

Rinse with 20 ml Antiseptic Mouthwash for 30 seconds, twice daily (morning and evening). Then rinse with water. Do not swallow. Not indicated below 12 years of age.

Do not rinse, eat, or smoke for thirty minutes after using a mouthwash. Doing so will diminish the effects of the mouthwash.

Hypersensitivity

Do not swallow. It is not indicated below 12 years of age. Keep out of the reach of children. Keep in a cool and dry palace. Do not use if cap seal is broken.

There are no known drug interactions and none well documented.

Pregnancy Category - Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Dental cavities, Tooth decay, Bad breath, Dental plaque, Gingivitis

Oral preparations

Eucalyptol is a natural organic compound which is a colorless liquid. It is a cyclic ether and a monoterpenoid. Eucalyptol is an ingredient in many brands of mouthwash and cough suppressant. It controls airway mucus hypersecretion and asthma via anti-inflammatory cytokine inhibition.

Menthol: It provides cooling sensation by stimulation of cooling receptor and gives local anesthetic action

Methyl Salicylate: It penetrates and reaches at high concentration in pain regions and inhibit the prostaglandin synthesis and relieves pain effectively

Thymol, one of the chemicals in thyme, is used with another chemical, chlorhexidine, as a dental varnish to prevent tooth decay. In foods, thyme is used as a flavoring agent. In manufacturing, red thyme oil is used in perfumes. It is also used in soaps, cosmetics, and toothpastes.

Fluoride salts are often added to municipal drinking water (as well as certain food products in some countries) for the purposes of maintaining dental health. The fluoride enhances the strength of teeth by the formation of fluorapatite, a naturally occurring component of tooth enamel. Toothpaste often contains sodium fluoride to prevent cavities, although tin(II) fluoride is generally considered superior for this application.

Adults and children 6 years of age and older: Rinse full strength for 1 minute with 10 ml in morning and night. Do not swallow.

Children under 6 years of age: Consult a dentist or doctor.

Local irritation of mouth, nausea & vomiting.

Hypersensitivity

Do not swallow. It is not indicated below 12 years of age. Do not rinse, eat, or smoke for thirty minutes after using a mouthwash. Doing so will diminish the effects of the mouthwash.

There are no known drug interactions and none well documented.

Pregnancy Category: Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Store in a cool & dry place. Keep out of reach of children. Cold weather may cloud this product but its antiseptic & anticavity properties are not affected.

Cetrimide & Chlorhexidine Hydrochloride is indicated in Insect bites, Sunburn, Disinfection, Cuts, Scratches, Blisters, Grazes, Nappy rash, Cracked and itchy skin, Cleansing and irrigating the skin or dirty wounds

Chlorhexidine & Chloroxylenol preparations

Cetrimide is a quaternary ammonium antiseptic; it has bactericidal activity against both gram-positive and gram-negative organisms. Chlorhexidine is an antimicrobial agent; it is active against a wide range of gram-negative and gram-positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses.

Adult and children: Apply 2-3 times daily or as directed.

Repeated application may lead to skin irritation.

Not to be used in the eye, ear, mucous membrane or body cavities.

Prolonged and repeated use may increase risk of hypersensitivity reactions. Blood, soap, cotton or other organic matter may decrease antibacterial efficacy.

There are no known drug interactions and none well documented.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

For the treatment of women with severe acne, unresponsive to oral antibiotic and other available treatments, with associated symptoms of androgenization, including seborrhea and mild hirsutism.

Oral Contraceptive preparations, Oral Hormonal preparations for Acne

Cyproterone is a steroid compound with potent antiandrogenic, progestogenic and antigonadotrophic activity. It exerts its antiandrogenic effect by blocking androgen receptors. It also reduces androgen synthesis by a negative feedback effect on the hypothalamo-pituitary-ovarian systems. The estrogen component (Ethinylestradiol) increases levels of sex hormone binding globulin (SHBG) and thus reduces the free circulating plasma levels of androgens. Cyproterone has no tendency to reduce SHBG levels.

If used alone in women,Cyproterone leads to menstrual cycle disturbances which are avoided when combined with Ethinylestradiol. When this tablet is administered in a cyclic manner, it has the added effect of preventing ovulation and possible conception.

The components of this tablet are rapidly absorbed after oral administration. Due to the long terminal half-life of Cyproterone, a 4-fold increase in plasma levels occurs after 6 to 12 days of daily dosing. Long-term therapy (36 months) with this product did not have a significant influence on lipid metabolism. A trend to increase plasma cholesterol and triglyceride levels was observed. There was a slight decrease in low density lipoprotein (LDL) with a simultaneous increase in high density lipoprotein (HDL).

This tablet should not be prescribed solely for its contraceptive properties. If patient compliance is uncertain and contraception is necessary, then a supplementary nonhormonal contraceptive method should be considered.

First Treatment Course: The patient is instructed to take 1 tablet daily for 21 consecutive days beginning on day 1 of her menstrual cycle. (For the first cycle only the first day of menstrual flow is considered Day 1). The tablets are then discontinued for 7 days (1 week). Withdrawal bleeding should usually occur during the period that the patient is off the tablets.The first cycle will be somewhat shorter than usual, whereas all following cycles will last 4 weeks. The patient should be instructed to take the first tablet from the blister pack out of the section marked with the corresponding day (for example "Mon" for Monday) of the week and swallow it with some liquid. The patient should be instructed to take the tablet at the same time each day.

Subsequent Courses: The patient begins her next and all subsequent 21-day course of tablets (following the same 21 days on, 7 days off) on the same day of the week that she began her first course. She begins taking her tablets 7 days after discontinuation,regardless of whether or not withdrawal bleeding is still in progress.

Treatment should be continued for several months,since improvement may not be observed for at least 3 months. The need to continue treatment with This tablet should be evaluated periodically by the treating physician. This drug should be discontinued 3 to 4 cycles after signs have completely resolved.

Pregnancy should be ruled out before continuing treatment with This tablet in patients who have missed a menstrual period, if pregnancy is suspected, medication should be discontinued.

Missed dose: If the patient forgets to take a tablet at the usual time, the tablet may be taken within the next 12 hours. If more than 12 hours have elapsed from the time of usual administration, the patient must discard the missed tablet and continue to take the remaining tablets in the pack at the usual time in order to avoid premature withdrawal bleeding during this cycle. A supplementary nonhormonal method of contraception must be employed until the pack is empty to prevent pregnancy which would necessitate immediate discontinuation of this treatment.

Common side effects are Bleeding, Dizziness, Depression, Weight gain, Headache, Edema, Breast pain, Lactation, Blood clot, Gallstones.
.

Predisposing Factors for Coronary Artery Diseases: In women with predisposing factors for coronary artery disease (such as cigarette smoking, hypertension; hypercholesterolemia, obesity, diabetes and increasing age), the use of estrogen or progestogen combinations have been reported as an additional risk factor. After the age of 35 years, estrogen or progestogen combinations should be considered only in exceptional circumstances and when the risk/benefit ratio has been carefully weighed by both the patient and the physician. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from the use of this class of medication. This risk increases with age and heavy smoking (15 or more cigarettes per day) and is more marked in women over 35 years of age. Women who use such medication should not smoke. Estrogen/progestogen combinations may cause an increase in plasma lipoproteins and should be administered with caution to women known to have pre-existent hyperlipoproteinemia. Lipid profiles should be determined regularly in these patients. The combination of obesity, hypertension and diabetes is particularly hazardous to women who are taking this class of medication. To avoid this triad of conditions develop, the patient should be placed on an alternate form of therapy.

Discontinue medication at the earliest manifestation of: Thromboembolic and cardiovascular disorders such as: thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis. The use of estrogen/progestogen-combination products should be avoided in conditions which predispose to venous stasis and to vascular thrombosis, e.g. immobilization after accidents or confinement to bed during long-term illness. Under such conditions other nonhormonal methods of treatment should be considered. For use when surgery is contemplated, see Precautions.

• Visual defects, partial or complete.
• Papilledema, or ophthalmic vascular lesions.
• Severe headache of unknown etiology, or worsening of pre-existing migraine headache.
• Onset of jaundice or hepatitis.
• Itching of the whole body.

Hypertension: Patients with essential hypertension whose blood pressure is wellcontrolled may be given the drug but only under close supervision. If a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during the administration of the drug, cessation of medication is necessary.

Migraine and Headache: The onset or exacerbation of migraine or the development of headache of a new pattern which is recurrent persistent or severe, requires discontinuation of medication and evaluation of the cause.

Diabetes: Diabetic patients, or those with a family history of diabetes, should be observed closely to detect any alterations in carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given estrogen/progestogen combinations under strict medical supervision. Young diabetic patients whose disease is of recent origin, well-controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes should be closely observed.

Concurrent use of the following drugs may result in reduced efficacy of this tablet and increased incidence of breakthrough bleeding: Ampicillin, Analgesics, Antihistamines, Antimigraine preparations, Chloramphenicol, Griseofulvin, Isoniazid, Neomycin, Nitrofurantain, Penicillin V, Phenylbutazone, Sulfonamides and Tetracycline.

Concurrent use of anticoagulants with estrogen/progestogen combinations may reduce the anticoagulant effect. Effectiveness of the following drugs may be altered when used concurrently: Antihypertensive, Benzodiazepines (those that undergo oxidative degradation), Beta-adrenergic blockers,Caffeine, Corticosteroids, Hypoglycemic, Phenothiazine, Theophylline, Tricyclic antidepressants and Vitamins.

Concurrent use of the following drugs may reduce the efficacy of this tablet because of accelerated estrogen metabolism caused by the induction of hepatic enzymes: Carbamazepine, Phenobarbital, Phenytoin, Pyrimidine and Rifampicin.

Diabetics using estrogen/progestogen combinations may require adjustment of their antidiabetic medication. Concurrent administration of vitamin C (ascorbic acid) with estrogen/ progestogen combinations has been reported to result in a significant rise in plasma Ethinylestradiol levels.

Rule out pregnancy before treatment is begun. Because of the antiandrogenic action of this tablet,feminization of male fetuses has occurred in animal studies and may possibly occur in humans.

Fetal abnormalities have been reported to occur in the offspring of women who have taken estrogen/progestogen combinations in early pregnancy. Rule out pregnancy as soon as it is suspected. The use of estrogen/progestogen combinations during the period a mother is breast-feeding her infant may not be advisable. The hormonal components are excreted in breast milk and may reduce its quantity and quality. The long-term effects on the developing child are not known. This drug may cause fluid retention, conditions such as epilepsy.

Symptoms and Treatment:There have been no reports of overdose with this tablet. There are no specific antidotes and treatment should be symptomatic, based on the knowledge of the pharmacological action of the constituents.

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

Clindamycin cream is indicated in the treatment of bacterial vaginosis. Clindamycin cream can be used to treat non pregnant women and pregnant women during the second and third trimester.

Macrolides

Clindamycin Phosphate is a water soluble ester that derived from the parent antibiotic Lincomycin. Clindamycin inhibits bacterial protein synthesis by binding preferentially to the 50s ribosomal subunit and affects the process of peptide chain initiation. In vitro Clindamycin is active against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

• Bacteroides spp.
• Gardnerella vaginalism
• Mobiluncus spp.
• Mycoplasma hominis
• Peptostreptococcus spp.

One applicator full (approximately 5 gram) intravaginally at bedtime for 7 consecutive days. In patients in whom a shorter treatment course is desirable, a 3-day regimen has been shown to be effective.

Clindamycin may results the following side effects. Genital tract: vaginitis, vulvo-vaginal irritation Central nervous system: dizziness, headache, vertigo.Gastro-intestinal: heartburn, nausea, vomiting, diarrhea, constipation, abdominal pain. Dermatological: rash, exanthema. Hypersensitivity: urticaria.

Clindamycin cream is not recommended in children under 12 years of age.

The patient should be instructed not to engage in vaginal intercourse, or use other vaginal products during treatment with this product. This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, use of such products within 72 hours following treatment with Clindamycin cream is not recommended.

There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. This drug should be used during the first trimester of pregnancy only if clearly needed. There is no restriction to use Clindamycin cream during the second and third trimester. It is not known if clindamycin is excreted in breast milk following the use of vaginally administered Clindamycin phosphate. However, orally and parenterally administered Clindamycin has been reported to appear in breast milk.

Intravaginal overdose is not possible. Accidental ingestion of the product could be accompanied by effects related to therapeutic levels of oral clindamycin.

Store the tube below 25 °C, away from light & moisture. Keep out of the reach of children.

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Macrolides

Dosage of Clindamycin Capsule:

• Serious Infections: 150 mg-300 mg every six hours.
• More severe infections: 300 mg-450 mg every six hours.

To avoid the possibility of oesophageal irritation, Clindacin capsules should be taken with a full glass of water.

Several researches has found that Clindamycin 300 mg capsule provides plasma concentration over MIC₉₀ for more than 12 hours. This finding supports the twice-daily dosing of Clindacin 300 mg capsule, particularly in SSTIs & RTIs. However, in case of bone & joint infections, diabetic foot infections dose of Clindamycin should be 300 mg capsule 3-4 times daily.

Dosage of Clindamycin Powder for oral solution:

• Serious infections: 8-12 mg/kg/day divided into 3 or 4 equal doses.
• Severe infections: 13-16 mg/kg/day divided into 3 or 4 equal doses.
• More severe infections: 17-25 mg/kg/day divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, 1/2 teaspoon (37.5 mg) three times a day should be considered the minimum recommended dose.

Dosage of Clindamycin IV/IM Injection:
Adults-

• Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes: 600-1200 mg/day in 2- 4 equal doses.
• More severe infections: 1200-2700 mg/day in 2-4 equal doses.
• For more serious infections: these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes, these doses may be increased.
• Doses of as much as 4800 mg daily have been given intravenously to adults. Single intramuscular injections of greater than 600 mg are not recommended.

Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower effective dosage may be adequate for small prematures.

Pediatric patients (1 month of age to 16 years):

• 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections.
• Parenteral therapy may be changed to Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.
• In cases of (3-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

The adverse effects have been reported with the use of clindamycin are- abdominal pain, oesophagitis and oesophagial ulcer, nausea, vomiting and diarrhoea, pruritus, skin rashes, urticaria.

Clindamycin is contraindicated in patients previously found to be sensitive to clindamycin or any of the ingredients of this medicine.

Clindamycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Clindamycin enhances the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.

Pregnancy Category B. Clindamycin crosses the placenta in humans. After multiple doses, amniotic fluid concentrations were approximately 30% of maternal concentrations. Clindamycin should be used in pregnancy only if clearly needed. Clindamycin has been reported to appear in breast milk. Therefore, it is not recommended for nursing mothers if not clearly needed.

Use in newborns and infants: When Clindamycin is administered to newborns and infants (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric use: Dose adjustment of Clindamycin is not necessary.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Overdosage should be treated with simple gastric lavage. No specific antidote is known.

Direction for reconstitution (powder for oral solution): Shake the bottle well to loosen the powder. Add 80 ml of boiled and cooled water to the dry mixture in the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in solution. Keep the bottle tightly closed. The reconstituted solution should be used within 2 weeks if kept at room temperature.

Dilution of Clindamycin injection for intravenous use: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml. Infusion rates should not exceed 30 mg per minute.

• Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
• Single IM injections of greater than 600 mg are not recommended. Dilution is not required for intramuscular administration.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin phosphate Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

Physico-Chemical Stability of diluted solutions of Clindacin Injection-

• Room temperature: 16 days at 25°C.
• Refrigeration: 32 days at 4°C.

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

Adjunct anti-epileptic drugs, Benzodiazepine hypnotics

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.

Oral:

• Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

• The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

Injection:

• Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.

• Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.

The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.

It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.

Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.

Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.

Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.

Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.

Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.

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

Adjunct anti-epileptic drugs, Benzodiazepine hypnotics

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.

Oral:

• Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

• The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

Injection:

• Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.

• Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.

The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.

It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.

Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.

Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.

Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.

Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.

Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.

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

Adjunct anti-epileptic drugs, Benzodiazepine hypnotics

Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.

There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.

Oral:

• Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.

• The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.

Injection:

• Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.

• Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.

The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.

It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.

When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.

Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.

Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.

Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. 

Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.

Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.

Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.

Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.

Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.

Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.

Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.

Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.

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

Parenteral anti-coagulants

Enoxaparin Sodium is a low molecular weight heparin with a high anti-Xa activity and low anti-lla or antithrombin activity. At doses required for the various indications, Enoxaparin Sodium does not increase bleeding time. At preventive doses, Enoxaparin Sodium causes no notable modification of activated Partial Thromboplastin Time (aPTT). It neither influences platelet aggregation nor binding of fibrinogen to platelets. Enoxaparin Sodium is primarily metabolised in the liver.

Treatment of deep vein thrombosis, with or without pulmonary embolism: Subcutaneously 100 anti-Xa lU/kg twice daily for 10 days or Subcutaneously 150 anti-Xa lU/kq once daily for 10 days. Oral anticoagulant therapy should be initiated when appropriate and Enoxaparin Sodium treatment should be continued until a therapeutic anticoaqulant effect has been achieved.

Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin: Subcutaneously 100 anti-Xa lU/kg twice daily for 2- 8 days. Should be administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Enoxaparin Sodium in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilization.

Prevention of thrombus formation in extra corporeal circulation during hemodialysis: Recommended dose is 100 anti-Xa lU/kg. For patients with a high risk of hemorrhage, the dose should be reduced to 50 anti-Xa lU/kg for double vascular access or 75 anti-Xa lU/kg for single vascular access. During hemodialysis, Enoxaparin Sodium should be introduced into the arterial line of the circuit at the beqinninq of the dialysis session.

Prophylaxis of venous thromboembolic disease in surgical patients:

• Patients undergoing general surgery with a moderate risk of thromboembolism (e.g. abdominal surgery): Subcutaneously 2000 anti-Xa IU (0.2 ml) or 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 2 hours before the surgical procedure.
• Patients undergoing orthopedic surgery with a high risk of thromboembolism: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 7 to 10 days. The first injection should be given 12 hours before the surgical procedure. Longer treatment duration may be appropriate in some patients like continued therapy with 4000 anti-Xa IU once daily for 3 weeks following the initial therapy has been proven to be beneficial in orthopaedic surqery.

Prophylaxis of venous thromboembolic disease in medical patients: Subcutaneously 4000 anti-Xa IU (0.4 ml) once daily for 6- 14 days.

Haemorrhage (bleeding), Thrombocytopenia, elevations of serum aminotransferase. Pain, bluish marks at injection sites to skin rash at injection sites. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal/epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries.

Patients with known hypersensitivity to Enoxaparin Sodium, heparin or other low molecular weight heparins. Patients with active major bleeding and conditions with a high risk of uncontrolled hemorrhage including recent hemorrhagic stroke.

Enoxaparin Sodium should be injected by deep subcutaneous route in prophylactic and curative treatment and by intravascular route during hemodialysis. Do not administer by the intramuscular route. Enoxaparin Sodium should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy and recent neuro- or ophthalmologic surgery, concomitant use of medications affecting hemostasis. It is recommended that the platelet counts be measured before the initiation of the treatment and regularly thereafter during treatment.

It is recommended that agents which affect hemostasis should be discontinued prior to Enoxaparin Sodium therapy unless strictly indicated. These agents include medications such as: acetylsalicylic acid (and derivatives), NSAIDs (including ketorolac), ticlopidine,clopidogrel,dextran 40,glucocorticoids, thrombolytics and anticoagulants, other antiplatelet aggregation agents including glycoprotein llb/llla antagonists. If the combination is indicated, should be used with careful clinical and laboratory monitoring.

Pregnancy category B. In humans, there is no evidence that Enoxaparin Sodium crosses the placental barrier. As there are no adequate and well-controlled studies in pregnant women, Enoxaparin Sodium should be used during pregnancy only if clearly needed. Pregnant women with mechanical prosthetic heart valves may be at a higher risk for thromboembolism.

It is not known whether Enoxaparin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue Enoxaparin, taking into account the importance of Enoxaparin to the mother and the known benefits of nursing.

Dose in Elderly Patients: No dosage adjustment is necessary, unless kidney function is impaired.

Dose in Renal Impairment: Although no dosage adjustment is recommended in patients with moderate (creatinine clearance: 30-50 ml/min) and mild (creatinine clearance: 50 80 ml/min) renal impairment, all such patients should be observed carefully for signs and symptoms of bleeding. For patients with severe (creatinine clearance <30 ml/min) renal impairment, following dosage adjustments are recommended: Prophylactic dose ranges: 2000 antiXa IU once daily; Therapeutic dose ranges: 100 anti-Xa lU/kg once daily.

Dose in Hepatic Impairment: Caution should be used in hepatically impaired patients.

Accidental overdosage following administration of Enoxaparin may lead to hemorrhagic complications. Injected Enoxaparin may be largely neutralized by the slow i.v. injection of protamine sulfate (1% solution) The dose of protamine sulfate should be equal to the dose of Enoxaparin injected: 1 mg protamine sulfate should be administered to neutralize 1 mg Enoxaparin.

Store in a cool and dry place, protect from light and moisture. Do not store above 25°C. Do not store in a refrigerator or freezer. Keep out of the reach of children