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Hormone preparations for other uses

The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. (1) Progesterone plays a vital role in regulation of the female reproductive system and is important for successful implantation of the embryo and maintenance of pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and in the central nervous system. These receptors exist in 2 isoforms, PR-A and PR-B. Progesterone binding to these receptors ultimately leads to regulation of gene transcription. (2) This results in an anti-inflammatory effect which blunts the proinflammatory state that occurs with initiation of labor, and maintains uterine queiscence by stabilizing progesterone acting on the myometrium.

Administer intramuscularly at a dose of 500 mg or 250 mg once weekly. Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Administration-

1. Clean the ampoule top with an alcohol swab before use.
2. Draw up 1 ml of drug into a 2 ml syringe.
3. After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
4. Applying pressure to the injection site may minimize bruising and swelling.

Most Common: Injection site reactions (pain, swelling, pruritus, nodule), Hives, Itching, nausea, and diarrhea. Call your doctor if you get any of the symptoms below:

• Blood clots Symptoms: Leg swelling, Redness in your leg, a spot on your leg that is warm to touch, Leg pain that worsens when you bend your foot.
• Allergic reactions: Hives, Itching, Swelling of the face.

Pregnancy: Category B. No adequate and well-controlled studies in women during first trimester of pregnancy. Teratogenic risks to infants following in utero exposure to the drug not demonstrated in a study of pregnant women receiving the drug during their second and third trimesters, as well as in a follow-up safety study of their infants. Not intended to stop active preterm labor; effect of drug for this use unknown.

Lactation: Detectable amounts of progestins identified in the breast milk of women receiving progestins. No adverse effects of progestins on breastfeeding performance or on health, growth, or development of infants, Discontinue drug at 37 weeks of gestation or upon delivery.

Pediatric Use: Not indicated for use in pediatric patients. Safety and efficacy not established in pediatric patients <16 years of age. Limited number of women<18 years of age studied; safety and efficacy expected to be the same in women >16 years of age compared with those > 18 years of age.

Geriatric Use: Not evaluated in women >65 years of age. Not intended for use in postmenopausal women. Safety and efficacy not established in postmenopausal women.

Hepatic Impairment: Contraindicated in patients with liver tumors (benign or malignant) or active liver disease. Effect of hepatic impairment on pharmacokinetics of the drug not evaluated.

Renal Impairment: Effect of renal impairment on pharmacokinetics of the drug not evaluated.

No adverse events associated with overdosage has been reported.

Store at controlled room temperature between 15°C to 30°C. Protects from light. Keep out of the reach of children.

Hormone preparations for other uses

The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. (1) Progesterone plays a vital role in regulation of the female reproductive system and is important for successful implantation of the embryo and maintenance of pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and in the central nervous system. These receptors exist in 2 isoforms, PR-A and PR-B. Progesterone binding to these receptors ultimately leads to regulation of gene transcription. (2) This results in an anti-inflammatory effect which blunts the proinflammatory state that occurs with initiation of labor, and maintains uterine queiscence by stabilizing progesterone acting on the myometrium.

Administer intramuscularly at a dose of 500 mg or 250 mg once weekly. Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Administration-

1. Clean the ampoule top with an alcohol swab before use.
2. Draw up 1 ml of drug into a 2 ml syringe.
3. After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
4. Applying pressure to the injection site may minimize bruising and swelling.

Most Common: Injection site reactions (pain, swelling, pruritus, nodule), Hives, Itching, nausea, and diarrhea. Call your doctor if you get any of the symptoms below:

• Blood clots Symptoms: Leg swelling, Redness in your leg, a spot on your leg that is warm to touch, Leg pain that worsens when you bend your foot.
• Allergic reactions: Hives, Itching, Swelling of the face.

Pregnancy: Category B. No adequate and well-controlled studies in women during first trimester of pregnancy. Teratogenic risks to infants following in utero exposure to the drug not demonstrated in a study of pregnant women receiving the drug during their second and third trimesters, as well as in a follow-up safety study of their infants. Not intended to stop active preterm labor; effect of drug for this use unknown.

Lactation: Detectable amounts of progestins identified in the breast milk of women receiving progestins. No adverse effects of progestins on breastfeeding performance or on health, growth, or development of infants, Discontinue drug at 37 weeks of gestation or upon delivery.

Pediatric Use: Not indicated for use in pediatric patients. Safety and efficacy not established in pediatric patients <16 years of age. Limited number of women<18 years of age studied; safety and efficacy expected to be the same in women >16 years of age compared with those > 18 years of age.

Geriatric Use: Not evaluated in women >65 years of age. Not intended for use in postmenopausal women. Safety and efficacy not established in postmenopausal women.

Hepatic Impairment: Contraindicated in patients with liver tumors (benign or malignant) or active liver disease. Effect of hepatic impairment on pharmacokinetics of the drug not evaluated.

Renal Impairment: Effect of renal impairment on pharmacokinetics of the drug not evaluated.

No adverse events associated with overdosage has been reported.

Store at controlled room temperature between 15°C to 30°C. Protects from light. Keep out of the reach of children.

Mefenamic Acid is indicated for-

• Fever
• Toothache
• Headache
• Migraine
• Primary dysmenorrhoea
• Menorrhagia
• Mild to moderate pain in rheumatoid arthritis and osteoarthritis
• Traumatic pain
• Low-back pain
• Juvenile chronic arthritis in children etc.

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

Mefenamic acid contains Mefenamic Acid which is a nonsteroidal agent with demonstrated analgesic, anti-inflammatory and antipyretic activity due to its dual action on prostaglandins. It inhibits the enzymes of prostaglandin synthetase and also antagonizes the actions of prostaglandin at the receptor sites.

Adult:

• 500 mg dose should be given to adults upto three times (1.5 gm total) per day with meals. The dosage may be reduced to 1 tablet (250 mg) three times daily.
• In case of menorrhagia: 500 mg three times daily with meals and from the onset of menses and continued according to the judgement of the physician.

Children:

• 6 months to 1 year: 5 ml three times/day.
• 2-4 years: 10 ml three times/day.
• 5-8 years: 10 ml four times /day.
• 9-12 years: 15 ml four times/day.

Treatment should not be continued for more than 7 days except on the advice of a physician.

The most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea, Gl ulcers, vomiting, dizziness, abnormal renal function, pruritus, rashes.

It is contraindicated in patients with known hypersensitivity to Mefenamic Acid. It should not be used in patients with peptic ulcer, inflammatory bowel diseases, hepatic or renal impairment. It is also contraindicated in patients, whom aspirin and/or other NSAID's have induced symptoms of bronchospasm, skin rashes etc.

It should be administered with caution in allergic diseases especially in asthma. The treatment should be withdrawn in diarrhoea, rashes, cholestatic jaundice, thrombocytopenia, haemolytic anaemia.

Aspirin: As other NSAIDs, concomitant administration of Mefenamic Acid and Aspirin is not generally recommended because of the potential of increased adverse effects.

Warfarin: Mefenamic Acid can inhibit platelet aggregation and may prolong the prothrombin time in patients on warfarin therapy

The safety of Mefenamic acid on reproductive capacity and pregnancy has not been established. Thus, mefenamic acid should be used in women of childbearing potential and during pregnancy only when the potential benefits are expected to outweigh the potential risks. Trace amounts of Mefenamic acid may be present in breast milk and transmitted to the nursing infant. Thus Mefenamic acid should not be taken by the nursing mother because of the effects of this class of drugs on the infant's cardiovascular system.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Mefenamic Acid is indicated for-

• Fever
• Toothache
• Headache
• Migraine
• Primary dysmenorrhoea
• Menorrhagia
• Mild to moderate pain in rheumatoid arthritis and osteoarthritis
• Traumatic pain
• Low-back pain
• Juvenile chronic arthritis in children etc.

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

Mefenamic acid contains Mefenamic Acid which is a nonsteroidal agent with demonstrated analgesic, anti-inflammatory and antipyretic activity due to its dual action on prostaglandins. It inhibits the enzymes of prostaglandin synthetase and also antagonizes the actions of prostaglandin at the receptor sites.

Adult:

• 500 mg dose should be given to adults upto three times (1.5 gm total) per day with meals. The dosage may be reduced to 1 tablet (250 mg) three times daily.
• In case of menorrhagia: 500 mg three times daily with meals and from the onset of menses and continued according to the judgement of the physician.

Children:

• 6 months to 1 year: 5 ml three times/day.
• 2-4 years: 10 ml three times/day.
• 5-8 years: 10 ml four times /day.
• 9-12 years: 15 ml four times/day.

Treatment should not be continued for more than 7 days except on the advice of a physician.

The most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea, Gl ulcers, vomiting, dizziness, abnormal renal function, pruritus, rashes.

It is contraindicated in patients with known hypersensitivity to Mefenamic Acid. It should not be used in patients with peptic ulcer, inflammatory bowel diseases, hepatic or renal impairment. It is also contraindicated in patients, whom aspirin and/or other NSAID's have induced symptoms of bronchospasm, skin rashes etc.

It should be administered with caution in allergic diseases especially in asthma. The treatment should be withdrawn in diarrhoea, rashes, cholestatic jaundice, thrombocytopenia, haemolytic anaemia.

Aspirin: As other NSAIDs, concomitant administration of Mefenamic Acid and Aspirin is not generally recommended because of the potential of increased adverse effects.

Warfarin: Mefenamic Acid can inhibit platelet aggregation and may prolong the prothrombin time in patients on warfarin therapy

The safety of Mefenamic acid on reproductive capacity and pregnancy has not been established. Thus, mefenamic acid should be used in women of childbearing potential and during pregnancy only when the potential benefits are expected to outweigh the potential risks. Trace amounts of Mefenamic acid may be present in breast milk and transmitted to the nursing infant. Thus Mefenamic acid should not be taken by the nursing mother because of the effects of this class of drugs on the infant's cardiovascular system.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Mefenamic Acid is indicated for-

• Fever
• Toothache
• Headache
• Migraine
• Primary dysmenorrhoea
• Menorrhagia
• Mild to moderate pain in rheumatoid arthritis and osteoarthritis
• Traumatic pain
• Low-back pain
• Juvenile chronic arthritis in children etc.

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

Mefenamic acid contains Mefenamic Acid which is a nonsteroidal agent with demonstrated analgesic, anti-inflammatory and antipyretic activity due to its dual action on prostaglandins. It inhibits the enzymes of prostaglandin synthetase and also antagonizes the actions of prostaglandin at the receptor sites.

Adult:

• 500 mg dose should be given to adults upto three times (1.5 gm total) per day with meals. The dosage may be reduced to 1 tablet (250 mg) three times daily.
• In case of menorrhagia: 500 mg three times daily with meals and from the onset of menses and continued according to the judgement of the physician.

Children:

• 6 months to 1 year: 5 ml three times/day.
• 2-4 years: 10 ml three times/day.
• 5-8 years: 10 ml four times /day.
• 9-12 years: 15 ml four times/day.

Treatment should not be continued for more than 7 days except on the advice of a physician.

The most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal: abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea, Gl ulcers, vomiting, dizziness, abnormal renal function, pruritus, rashes.

It is contraindicated in patients with known hypersensitivity to Mefenamic Acid. It should not be used in patients with peptic ulcer, inflammatory bowel diseases, hepatic or renal impairment. It is also contraindicated in patients, whom aspirin and/or other NSAID's have induced symptoms of bronchospasm, skin rashes etc.

It should be administered with caution in allergic diseases especially in asthma. The treatment should be withdrawn in diarrhoea, rashes, cholestatic jaundice, thrombocytopenia, haemolytic anaemia.

Aspirin: As other NSAIDs, concomitant administration of Mefenamic Acid and Aspirin is not generally recommended because of the potential of increased adverse effects.

Warfarin: Mefenamic Acid can inhibit platelet aggregation and may prolong the prothrombin time in patients on warfarin therapy

The safety of Mefenamic acid on reproductive capacity and pregnancy has not been established. Thus, mefenamic acid should be used in women of childbearing potential and during pregnancy only when the potential benefits are expected to outweigh the potential risks. Trace amounts of Mefenamic acid may be present in breast milk and transmitted to the nursing infant. Thus Mefenamic acid should not be taken by the nursing mother because of the effects of this class of drugs on the infant's cardiovascular system.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Edema associated with congestive heart failure, hepatic cirrhosis, premenstrual tension and oedema due to various forms of renal dysfunction (i.e. nephrotic syndrome, acute glomerulonephritis, chronic renal failure). Hypertension, either alone or as an adjunct to other antihypertensive drugs.

Thiazide diuretics & related drugs

Thiazides such as hydrochlorothiazide promote water loss from the body (diuretics). They inhibit Na⁺/Cl^- reabsorption from the distal convoluted tubules in the kidneys. Thiazides also cause loss of potassium and an increase in serum uric acid. Thiazides are often used to treat hypertension, but their hypotensive effects are not necessarily due to their diuretic activity. Thiazides have been shown to prevent hypertension-related morbidity and mortality although the mechanism is not fully understood. Thiazides cause vasodilation by activating calcium-activated potassium channels (large conductance) in vascular smooth muscles and inhibiting various carbonic anhydrases in vascular tissue.

Edema: initially 25 to 50 mg daily, reduced for maintenance if possible; maximum 100 mg daily.

Hypertension: 25 mg daily, increased to 50 mg daily if necessary.

Elderly: in some patients, especially the elderly an initial dose of 12.5 mg daily may be sufficient.

Children: An initial dose for children has been 1 to 2 mg per kg body-weight in 2 divided doses. Infants under 6 months may need doses up to 3 mg per kg daily.

Gastro-intestinal system: Anorexia, gastric irritation, nausea, vomiting, cramps, diarrhoea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, salivary gland inflammation.

Central nervous system: Dizziness, vertigo, paraesthesiae, headache, yellow vision.

Heamatological: Leucopenia, agranulocytosis, thrombocytopenia, aplastic anaemia, haemolytic anaemia.

Cardiovascular: Hypotension, including orthostatic hypotension.

Hypersensitivity: Purpura, photosensitivity, rash, urticaria, necrotising angiitis (vasculitis, cutaneous vasculitis), fever, respiratiory distress including pneumonitis and pulmonary oedema, anaphylactic reactions, toxic epidermal necrolysis.

Metabolic: Hyperglycaemia, glycosuria, hyperuricaema, electrolyte imbalance including hyponatraemia and hypokalaemia.

Renal: Renal dysfunction, interstitial nephritis, renal failure.

Other: Muscle spasm, weakness, restlessness, transient blurred vision, impotence. Whenever side-effects are moderate to severe, thiazide dosage should be reduced or therapy was withdrawn.

Anuria, hypersensitivity to Hydrochlorothiazide or to other sulphonamide-derived drugs, severe renal or hepatic failure, Addison’s disease, hypercalcemia, concurrent lithium therapy.

Patients should be carefully monitored for signs of fluid and electrolyte imbalance (hyponatraemia, hypochloraemic alkalosis, hypokalaemia and hypomagnesaemia). It is particularly important to make serum and urine electrolyte determinations when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance include: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, seizures, confusion, muscle pains or cramps, muscle fatigue, hypotension, oliguria, tachycardia, and gastro-intestinal disturbances such as nausea and vomiting. Hypokalaemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. Hypokalaemia can sensitise or exaggerate the response of the heart to the toxic effects of digitalis (e.g. increased ventricular irritability). Sensitivity reactions may occur in patients with or without history of allergy or bronchial asthma. Hypokalaemia may be avoided or treated in the adult by concurrent use of amiloride hydrochloride, a potassium conserving agent. It may also be avoided by giving potassium chloride or foods with a high potassium content. Diuretic-induced hyponatraemia is usually mild and asymptomatic. Dilutional hyponatraemia may occur in oedematous patients in hot weather; and, except in rare instances when hyponatraemia is life-threatening, appropriate therapy is water restriction rather than administration of salt. Thiazides may decrease serum protein bound iodine levels without signs of thyroid disturbances. Thiazides may decrease urinary calcium excretion, and may also cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Thiazides should be discontinued before carrying out tests for parathyroid function. When creatinine clearance falls below 30ml/min, thiazide diuretics become ineffective. Uraemia may be precipitated or increased by chlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. If increasing uraemia and oliguria occur during treatment of renal disease, Hydrochlorothiazide should be discontinued. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Hyperuricaemia may occur, or gout may be precipitated, in certain patients receiving thiazide therapy. Thaizide therapy may impair glucose tolerance. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Latent diabetes may become manifest during thiazide administration.

Alcohol, barbiturates or narcotics: Co-administration may potentiate orthostatic hypotension. Oral and parenteral antidiabetic drugs may require adjustment of dosage with concurrent use. Other antihypertensive drugs may have an additive effect. Discontinuation of diuretic therapy 2-3 days before the initiation of treatment with an ACE inhibitor may reduce the likelihood of first-dose hypotension. The antihypertensive effect of the drug may be enhanced in the post-sympathectomy patient.

Cholestyramine and colestipol resin: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resin. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. Corticosteroids or ACTH may intensify any Thiazide-induced electrolyte depletion, particularly hypokalaemia. Pressor amines such as adrenaline may show decreased arterial responsiveness when used with hydrochlorothiazide, but this reaction is not enough to preclude their therapeutic usefulness. Non-depolarising muscle relaxants such as tubocurarine may possibly interact with Hydrochlorothiazide to increase muscle relaxation. Non-steroidal anti-inflammatory drugs may attenuate the diuretic and antihypertensive effects of diuretics.

Drug/laboratory tests: Because thiazides may affect calcium metabolism, Hydrochlorothiazide may interfere with tests for parathyroid function.

Use in pregnancy: Thiazides cross the placental barrier and appear in cord blood. The use of Hydrochlorothiazide when pregnancy is present or suspected requires, therefore, that the benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions, which have occurred in the adult. The routine use of diuretics in otherwise healthy pregnant women with or without mild oedema is not recommended, because their use may be associated with hypovolaemia, increased blood viscosity and decreased placental perfusion.

Use in breastfeeding mothers: Thiazides appear in breast milk. If use of the drug is deemed essential, the patient should stop breast-feeding.

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalaemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. If ingestion is recent, emesis should be induced or gastric lavage performed. Dehydration, electrolyte imbalance, hepatic coma and hypotension should be corrected by established methods. If required, give oxygen or artificial respiration for respiratory impairment.

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

Drugs for Dry eyes

Sodium hyaluronate is a polysaccharide which functions as a tissue lubricant. It is widely used in ophthalmic surgery because it forms a viscoelastic solution in water which makes it a suitable substitute for aqueous and vitreous humour.

Adult: Instill 1 drop 3 times daily. If necessary this can be increased or as directed by a physician.

Use in children: There is no known experience with patients under 18 years old.

Transient burning sensation, temporarily blurred vision and transient rise in intraocular pressure. Precautions: To avoid contamination, the tip of the container should not touch any surface and should be fully closed between applications.

Known hypersensitivity to any of the components.

Pregnancy category B. Reproductive studies have not demonstrated any risk, but no controlled studies in pregnant women are available. Sodium Hyaluronate has a purely physical effect on the eyes without being absorbed and hence can be used during pregnancy and lactation.

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

Drugs for Dry eyes

Sodium hyaluronate is a polysaccharide which functions as a tissue lubricant. It is widely used in ophthalmic surgery because it forms a viscoelastic solution in water which makes it a suitable substitute for aqueous and vitreous humour.

Adult: Instill 1 drop 3 times daily. If necessary this can be increased or as directed by a physician.

Use in children: There is no known experience with patients under 18 years old.

Transient burning sensation, temporarily blurred vision and transient rise in intraocular pressure. Precautions: To avoid contamination, the tip of the container should not touch any surface and should be fully closed between applications.

Known hypersensitivity to any of the components.

Pregnancy category B. Reproductive studies have not demonstrated any risk, but no controlled studies in pregnant women are available. Sodium Hyaluronate has a purely physical effect on the eyes without being absorbed and hence can be used during pregnancy and lactation.

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

Halobetasol Propionate 0.05% is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the Hypothalamic-Pituitary-Adrenal (HPA) axis.

Other Topical corticosteroids

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .

Apply a thin layer of Halobetasol Cream or Ointment to the affected skin once or twice daily, as directed by the physician, and rub in gently and completely. Halobetasol 0.05% is a super-high potency corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 gm/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Halobetasol should not be used with occlusive dressings.

The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, dryness, folliculitis acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy, secondary infections, striae and miliaria.

Halobetasol Propionate Cream/Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Systemic absorption of topical corticosteroids may cause reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.

Use in children under 12 years of age is not recommended. Safety and effectiveness of Halobetasol Propionate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.

Store below 30°C. Keep all medicines out of reach of children.

Intravenous fluid preparations

This Infusion injection comprises of a combination of medicines. It is given as a short term fluid replacement after trauma. This Infusion works by replenishing the body’s fluid and electrolytes. This injection should be administered under the supervision of a healthcare professional. You should not self administer this injection.

Some common side effects of this medicine can be injection site reactions such as redness, pain or swelling. If these side effects persist for a longer duration, please consult your doctor.

Hypersensitivity to any other ingredient of this preparation.

Before taking this medicine, tell your doctor if you have any other health conditions may be required. Inform your doctor if you are taking any other medicines or if you are pregnant or breastfeeding. It is advised not to consume alcohol after taking this medicine.

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

This is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

Adult or Elderly: 1 capsule daily. In more severe cases, 2 capsules daily may be required.

Children: Aged over 1 year: 1 capsule daily. The capsule may be opened and the pellets to be mixed with soft cool food, but they must not be chewed.

Dark stools are usual during iron therapy and nausea and other symptoms of gastrointestinal irritation such as anorexia, vomiting, discomfort, constipation and diarrhoea are sometimes encountered. Zinc may also produce a gastrointestinal upset. These timed-release capsules are designed to reduce the possibility of gastrointestinal irritation. There have been rare reports of allergic reactions

Do not use in patients hypersensitive to the components of the product or those with iron overload.

Care should be taken in patients who may develop Iron overloads, such as those with haemochromatosis, haemolytic anaemia or red cell aplasia. Failure to respond to treatment may indicate other causes of anaemia and should be further investigated. Iron & Zinc chelate with tetracycline and absorption of all three agents may be impaired. The absorption of Zinc may be reduced in the presence of Iron. Absorption of Iron may be impaired by penicillamine and by antacids. Such potential interactions can be reduced by separating the administration of each product by several hours. In patients with renal failure a risk of Zinc accumulation could exist.

Use of any drug during the first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of the pregnancy.

Iron overdosage is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, or if this is not possible vomiting should be induced. These procedures should not be undertaken where signs of the corrosive effects of zinc are present. Give oral desferrioxamine (2 gm for a child or 5 gm for an adult) and demulcent. If serum Iron levels at 4 hours or more post-ingestion are over 5mg/l in a child or 8 mg/l in adults, or if the patient is in shock of coma, intravenous desferrioxamine should be used. Zinc Sulphate in gross over dosage is corrosive. Symptoms are those of gastrointestinal irritation leading in severe cases to haemorrhage, corrosion of the mucosa and possible later stricture formation. Gastric lavage or emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as Dimercaprol, Penicillamine or Edetic Acid have been recommended.

Symptomatic and supportive measures should be given as required. The timed-release capsule presentation may delay excessive absorption of Iron and Zinc and allow more time for initiation of appropriate counter-measure.

Protected from light and moisture, store below 30˚C. Keep out of reach of children.

Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.

Other scalp preparations

Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.

Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the  dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.

Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.

For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.

Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.

Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.

Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.

Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

Minoxidil topical solution should not be used during pregnancy and lactation.

Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.

Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Store at a cool and dry place, protected from light. Keep out of the reach of the children.

Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.

Other scalp preparations

Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.

Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the  dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.

Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.

For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.

Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.

Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.

Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.

Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

Minoxidil topical solution should not be used during pregnancy and lactation.

Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.

Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Store at a cool and dry place, protected from light. Keep out of the reach of the children.

Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.

Other scalp preparations

Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.

Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the  dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.

Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.

For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.

Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.

Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.

Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.

Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

Minoxidil topical solution should not be used during pregnancy and lactation.

Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.

Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Store at a cool and dry place, protected from light. Keep out of the reach of the children.

Minoxidil is indicated in the treatment of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia, and also of alopecia areata.

Other scalp preparations

Minoxidil stimulates hair growth by increasing oxygen, blood and nutrients supply to the hair follicle by widening blood vessels and inhibiting androgen hormone to affect hair follicles.

Following topical application, an average of about 1.4% of the total applied dose is absorbed from the normal intact scalp. Topical Minoxidil absorption is increased by increasing the  dose applied, increasing the frequency of dosing and decreasing the barrier function of the stratum corneum. Serum Minoxidil levels and systemic effects resulting from the administration of topical Minoxidil are governed by the drug’s absorption rate through the skin. Following cessation of topical dosing, approximately 95% of the systemically absorbed drug is eliminated within 4 days. Minoxidil and its metabolites are excreted principally in the urine.

Minoxidil topical solution is for external use only and should be applied when the hair and scalp are clean and dry. Apply 1 ml (7 sprays) of Minoxidil topical solution twice daily at 12-hour intervals to the scalp, beginning at the centre of the affected area and spreading the solution out to cover the entire affected area. The total daily application dose should not exceed 2 ml.

For the best results, Minoxidil topical solution should be allowed to remain on the scalp for about 4 hours before washing. The night-time application should be done 2-4 hours before going to bed to allow the solution to dry out. Minoxidil topical solution should not be massaged into the scalp, but applied lightly. A hair dryer should not be used to speed up the drying of the solution as it may decrease the effectiveness. Minoxidil topical solution should not be mixed with any hair oil. The drug should not be used more than two times a day, or be taken orally or applied to any other part of the body to avoid the risk of adverse effects and unwanted hair growth. More frequent use or longer application time have no effect on hair growth. In case of missing any daily applications of Minoxidil topical solution, the patient should continue with the next application.

Hands should be washed immediately if Minoxidil topical solution is applied with the fingertips. Clinical experience with Minoxidil indicates that twice-daily applications for 4 months or more may be required before there is evidence of hair growth. To arrest hair fall, Minoxidil topical solution should be used for not less than 45 days. Depending upon the severity of hair loss or type and extent of baldness, particular strength of Minoxidil topical solution may be selected.

Commonly encountered side effects in clinical trials with Minoxidil topical solution were minor dermatological reactions. Dermatitis or hypertrichosis may occur. These incidences may occur in 0.1–5% of patients.

Minoxidil topical solution is more likely to cause scalp irritation. If scalp irritation continues or worsen, use of Minoxidil topical solution should be stopped.

Minoxidil topical solution should not be used along with other topical agents known to alter the stratum corneum barrier such as tretinoin or dithranol, due to the enhanced absorption of Minoxidil. Although there is no clinical evidence, there exists the theoretical possibility of absorbed Minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

Minoxidil topical solution should not be used during pregnancy and lactation.

Increased systemic absorption of Minoxidil may potentially occur if higher-than-recommended doses of Minoxidil are applied to larger surface areas of the body or areas other than the scalp. There are no known cases of Minoxidil overdosage resulting from topical administration of Minoxidil.

Signs and symptoms of Minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Store at a cool and dry place, protected from light. Keep out of the reach of the children.

This is indicated in loss of appetite, indigestion.

Herbal and Nutraceuticals

Piper longum-

• Chemical constituents: piperine, piplartine, essential oil, two liquid alkaloids-triacontane, sesamin etc.
• Action: It is used as nerve tonic, carminative, digestive and strengthen muscular system. It can use in haemorroids, splenic disorders.

Zingiber officinale-

• Chemical constituents: Zinziberin, zingerfone, terpenes, cineol, borneol, citral, camphene, phelandrene, gingerol, shogaol, etc.
• Actions: It is digestive, carminative, stomachic & stimulant. It is used in dyspepsia, flatulent, colic, vomiting and constipation.

Cinnamomum zeylanicum-

• Chemical constituents: Cinnamon contains volatile oil (1-6%), phlobatannin, mucilage, calcium oxalate, sugar and starch. The principal constituent of the volatile oil is cinnamic aldehyde (60-75%).
• Actions: Cinnamon is pungent, aromatic, astringent, stimulant and carminative. It is employed as flavoring agent. It has antiseptic and antidiarrhoeal properties and is a powerful germicide.

1-2 tablets 2/3 times daily.

Not yet known.

There is no absolute contraindication.

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Eribulin Mesylate is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Targeted Cancer Therapy

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G₂/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.

The recommended dose of Eribulin Mesylate is 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

The recommended dose of Eribulin Mesylate in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

The recommended dose of Eribulin Mesylate in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

The recommended dose of Eribulin Mesylate in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 1.1 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

The most common adverse reactions (incidence ≥25%) were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.

Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate.

Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with dose delay and adjustment.

Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome.

Effects of Other Drugs on Eribulin Mesylate: No drug-drug interactions are expected with CYP3A4 inhibitors or P-gp inhibitors. The effect of ketoconazole, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and a P-gp inhibitor, on the pharmacokinetics (PK) of eribulin was studied in an open-label, two-treatment, two-sequence, two-way crossover trial in 12 patients with advanced solid tumors. The mean dose-normalized AUC values were similar when eribulin was administered with or without ketoconazole (ratio of the mean AUC: 0.97; 90% CI: 0.83, 1.12).

Effect of Eribulin Mesylate on Other Drugs: Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4 enzymes or induce CYP1A2, CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Eribulin is not expected to alter the plasma concentrations of drugs that are substrates of these enzymes

Pregnancy Category D. There are no adequate and well-controlled studies with Eribulin Mesylate in pregnant women. It is not known whether Eribulin Mesylate is excreted into human milk. No studies in humans or animals were conducted to determine if Eribulin Mesylate is excreted into milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in human milk-fed infants from Eribulin Mesylate, a decision should be made whether to discontinue nursing or to discontinue Eribulin Mesylate taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of Eribulin in pediatric patients below the age of 18 years have not been established.

Geriatric Use: Study 1 did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Of the 827 subjects who received the recommended dose and schedule of Eribulin in clinical studies, 15% (121/827) were 65 and older, and 2% (17/827) patients were 75 and older. No overall differences in safety were observed between these subjects and younger subjects.

Hepatic Impairment: A lower starting dose is recommended for patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) were not studied.

Renal Impairment: A lower starting dose is recommended for patients with moderate (CrCl 30-50 mL/min) renal impairment. Patients with severe (CrCl < 30 mL/min) renal impairment were not studied.

Overdosage of Eribulin has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for Eribulin overdose.

Store at 25°C; excursions permitted to 15°-30°C. Do not freeze. Store the vials in their original cartons.

Halobetasol Propionate 0.05% is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the Hypothalamic-Pituitary-Adrenal (HPA) axis.

Other Topical corticosteroids

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .

Apply a thin layer of Halobetasol Cream or Ointment to the affected skin once or twice daily, as directed by the physician, and rub in gently and completely. Halobetasol 0.05% is a super-high potency corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 gm/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Halobetasol should not be used with occlusive dressings.

The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, dryness, folliculitis acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy, secondary infections, striae and miliaria.

Halobetasol Propionate Cream/Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Systemic absorption of topical corticosteroids may cause reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.

Use in children under 12 years of age is not recommended. Safety and effectiveness of Halobetasol Propionate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.

Store below 30°C. Keep all medicines out of reach of children.

Halobetasol Propionate 0.05% is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the Hypothalamic-Pituitary-Adrenal (HPA) axis.

Other Topical corticosteroids

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .

Apply a thin layer of Halobetasol Cream or Ointment to the affected skin once or twice daily, as directed by the physician, and rub in gently and completely. Halobetasol 0.05% is a super-high potency corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 gm/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Halobetasol should not be used with occlusive dressings.

The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, dryness, folliculitis acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy, secondary infections, striae and miliaria.

Halobetasol Propionate Cream/Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Systemic absorption of topical corticosteroids may cause reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.

Use in children under 12 years of age is not recommended. Safety and effectiveness of Halobetasol Propionate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.

Store below 30°C. Keep all medicines out of reach of children.

Halobetasol Propionate 0.05% is a super-high potent corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 gm/week because of the potential for the drug to suppress the Hypothalamic-Pituitary-Adrenal (HPA) axis.

Other Topical corticosteroids

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2 .

Apply a thin layer of Halobetasol Cream or Ointment to the affected skin once or twice daily, as directed by the physician, and rub in gently and completely. Halobetasol 0.05% is a super-high potency corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 gm/week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Halobetasol should not be used with occlusive dressings.

The following adverse effects have been reported infrequently with topical corticosteroids. These reactions include burning, itching, dryness, folliculitis acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin atrophy, secondary infections, striae and miliaria.

Halobetasol Propionate Cream/Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Systemic absorption of topical corticosteroids may cause reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of cushing's syndrome, hyperglycemia, and glucosuria. Patients receiving large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore caution should be exercised when topical corticosteroids are administered to a nursing woman.

Use in children under 12 years of age is not recommended. Safety and effectiveness of Halobetasol Propionate cream & ointment in paediatric patients have not been established. Paediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.

Store below 30°C. Keep all medicines out of reach of children.