Find Medicines

Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids

Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g. mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g. histamine, eicosanoids, leukotriene, and cytokine) involved in allergic mediated inflammation.

Adults and children 6 years of age and older: 100 mcg per day administered as one spray per nostril once daily.

Adults (12 years of age and older): The maximum recommended dose is 400 mcg per day administered as four sprays per nostril once daily.

Pediatric Use: Safety and effectiveness in pediatric patients below 6 years of age have not been established.

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Adverse local reactions following budesonide use are mild and usually transient. Systemic side effects have not been reported during clinical studies of budesonide nasal preparations. Sneezing, headache, sore throat, dry mouth, nausea etc. have been reported as the common side effects.

Budesonide nasal spray should be used with caution in patients with active or quiescent tuberculous infection, untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex infection. Patients with recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid.

No significant drug interaction has been reported.

Pregnancy: Inhaled budesonide has been assigned to pregnancy category B by the FDA. Budesonide has not been shown to be teratogenic in animals when given in high doses by inhalation. Despite the animal findings, it would appear that the possibility of fetal harm is remote if the inhaled drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, inhaled budesonide should be used during pregnancy only if clearly needed.

Lactation: The amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. Reviewers and an expert panel consider inhaled corticosteroids acceptable to use during breastfeeding. When taken by mouth, budesonide is only about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breastmilk.

Like any other nasally administered corticosteroids, acute overdosing is unlikely in view of the total amount of active ingredient present. Clinically significant systemic adverse events would most likely not occurs if the entire contents of the bottle were administered all at once, via either oral or nasal application. Chronic overdosage may result in signs/symptoms of hypercorticism.

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

Eszopiclone is indicated for the treatment of insomnia, including difficulty falling asleep and difficulty maintaining sleep through the night. Eszopiclone is the first sedative approved long-term use

Miscellaneous sedatives & hypnotics

Eszopiclone may interact with Gama-aminobutyric acid (GABA) receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.

The usual dose to improve or maintain sleep in most adults is 2 or 3 mg. Persons over the age of 65 years usually are treated with 1 or 2 mg. Eszopiclone should be taken immediately before going to bed since the onset of sedation may occur as rapidly as 10 minutes. It should be taken only by individuals who intend to sleep for at least 8 hours since its effects may last up to six hours.

Eszopiclone is generally well tolerated. However few side effects like fatigue, anorexia, nausea, unpleasant taste in the mouth, mood problems, abdominal pain, dyspepsia, asthenia, nervousness, dizziness and confusion have been reported.

Depression, Severe Chronic Obstructive Lung Disease, Severe Liver Disease, Weakened Patient, Having thoughts of Suicide.

Eszopiclone like all sedatives should be taken immediately before bedtime to avoid short-term memory impairment, hallucinations, impaired coordination, dizziness and lightheadedness

Alcohol (which causes sedation) and drugs that have sedating effects should not be used with Eszopiclone since their sedating effects, when added to those of Eszopiclone, may cause excessive sedation.

Pregnancy: Category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether the drug is excreted in breast milk. As many drugs are excreted in breast milk, caution should be exercised when Eszopiclone is administered to a nursing mother.

There is limited clinical experience with the overdose of Eszopiclone. In clinical trials one case of overdose with up to 36 mg of Eszopiclone has been reported in which the subject fully recovered. Intravenous fluids should be administered as needed & Flumazenil may be useful.

Store at 25°C.

Eszopiclone is indicated for the treatment of insomnia, including difficulty falling asleep and difficulty maintaining sleep through the night. Eszopiclone is the first sedative approved long-term use

Miscellaneous sedatives & hypnotics

Eszopiclone may interact with Gama-aminobutyric acid (GABA) receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.

The usual dose to improve or maintain sleep in most adults is 2 or 3 mg. Persons over the age of 65 years usually are treated with 1 or 2 mg. Eszopiclone should be taken immediately before going to bed since the onset of sedation may occur as rapidly as 10 minutes. It should be taken only by individuals who intend to sleep for at least 8 hours since its effects may last up to six hours.

Eszopiclone is generally well tolerated. However few side effects like fatigue, anorexia, nausea, unpleasant taste in the mouth, mood problems, abdominal pain, dyspepsia, asthenia, nervousness, dizziness and confusion have been reported.

Depression, Severe Chronic Obstructive Lung Disease, Severe Liver Disease, Weakened Patient, Having thoughts of Suicide.

Eszopiclone like all sedatives should be taken immediately before bedtime to avoid short-term memory impairment, hallucinations, impaired coordination, dizziness and lightheadedness

Alcohol (which causes sedation) and drugs that have sedating effects should not be used with Eszopiclone since their sedating effects, when added to those of Eszopiclone, may cause excessive sedation.

Pregnancy: Category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether the drug is excreted in breast milk. As many drugs are excreted in breast milk, caution should be exercised when Eszopiclone is administered to a nursing mother.

There is limited clinical experience with the overdose of Eszopiclone. In clinical trials one case of overdose with up to 36 mg of Eszopiclone has been reported in which the subject fully recovered. Intravenous fluids should be administered as needed & Flumazenil may be useful.

Store at 25°C.

Sodium Picosulfate is indicated in the following conditions-

• Constipation of any etiology
• Relief from prolonged & recurrent constipation
• Bowel clearance before surgery, childbirth or radiological investigations.

Osmotic purgatives

Sodium Picosulfate is a triarylmethane group derivative stimulant laxative. After oral administration it is activated by the colonic bacteria and acts locally in the colon. The active form then stimulates the nerve endings of the intestinal wall and results in colonic peristalsis with promotion of accumulation of water and electrolytes in the colonic lumen. This results in stimulation of defecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the "call to stool".

For oral administration. The following dosages are recommended to be taken at night to produce evacuation the following morning. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded:

Adults and children over 10 years of age-

• Tablet: 5-10 mg per day.
• Oral Solution: 5-10 ml or one to two teaspoonful per day.

Children are aged 4-10 years-

• Tablet: 2.5-5 mg per day.
• Oral Solution: 2.5-5 ml or Half to one teaspoonful per day.

Children under 4 years of age-

• Oral Solution: 0.25 ml/kg body weight per day.

Hypersensitivity, dizziness, syncope, vasovagal response, gastrointestinal disorders, diarrhea, abdominal pain and abdominal cramps, nausea, vomiting.

Ileus or intestinal obstruction, severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting, acute inflammatory bowel diseases, severe dehydration, known hypersensitivity to Sodium Picosulfate or any other component of the product.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalemia. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses are taken. Concurrent administration of antibiotics may reduce the laxative action of this product.

There are no reports of undesirable or damaging effects during pregnancy or to the foetus attributable to the use of this product. Use of the drug should be avoided during the first trimester. Clinical data show that neither the active moiety of sodium Picosulfate (BHPM or bis-(p hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Laxatives when taken in chronic overdosage may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and renal calculi. Renal tubular damage, metabolic alkalosis, and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse.

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

Sodium Picosulfate is indicated in the following conditions-

• Constipation of any etiology
• Relief from prolonged & recurrent constipation
• Bowel clearance before surgery, childbirth or radiological investigations.

Osmotic purgatives

Sodium Picosulfate is a triarylmethane group derivative stimulant laxative. After oral administration it is activated by the colonic bacteria and acts locally in the colon. The active form then stimulates the nerve endings of the intestinal wall and results in colonic peristalsis with promotion of accumulation of water and electrolytes in the colonic lumen. This results in stimulation of defecation, reduction of transit time and softening of the stool. Stimulation of the rectum causes increased motility and a feeling of rectal fullness. The rectal effect may help to restore the "call to stool".

For oral administration. The following dosages are recommended to be taken at night to produce evacuation the following morning. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded:

Adults and children over 10 years of age-

• Tablet: 5-10 mg per day.
• Oral Solution: 5-10 ml or one to two teaspoonful per day.

Children are aged 4-10 years-

• Tablet: 2.5-5 mg per day.
• Oral Solution: 2.5-5 ml or Half to one teaspoonful per day.

Children under 4 years of age-

• Oral Solution: 0.25 ml/kg body weight per day.

Hypersensitivity, dizziness, syncope, vasovagal response, gastrointestinal disorders, diarrhea, abdominal pain and abdominal cramps, nausea, vomiting.

Ileus or intestinal obstruction, severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting, acute inflammatory bowel diseases, severe dehydration, known hypersensitivity to Sodium Picosulfate or any other component of the product.

Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalemia. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

The concomitant use of diuretics or adreno-corticosteroids may increase the risk of electrolyte imbalance if excessive doses are taken. Concurrent administration of antibiotics may reduce the laxative action of this product.

There are no reports of undesirable or damaging effects during pregnancy or to the foetus attributable to the use of this product. Use of the drug should be avoided during the first trimester. Clinical data show that neither the active moiety of sodium Picosulfate (BHPM or bis-(p hydroxyphenyl)-pyridyl-2-methane) nor its glucuronides are excreted into the milk of healthy lactating females.

Laxatives when taken in chronic overdosage may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and renal calculi. Renal tubular damage, metabolic alkalosis, and muscle weakness secondary to hypokalemia have also been described in association with chronic laxative abuse.

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

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Targeted Cancer Therapy

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

Store at 25° C.

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Targeted Cancer Therapy

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

Store at 25° C.

Hepatocellular Carcinoma: Sorafenib is indicated for the treatment of patients with unresectablehepatocellular carcinoma (HCC).

Renal Cell Carcinoma: Sorafenib is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

Targeted Cancer Therapy

Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß). Several of these kinases are thought to be involved in tumor cell signaling, angiogenesis, and apoptosis. Sorafenib inhibited tumor growth and angiogenesis of human hepatocellular carcinoma and renal cell carcinoma, and several other human tumor xenografts in immunocompromised mice.

Advanced renal cell carcinoma: 400 mg bid. May continue until patient is no longer responding or unacceptable toxicity occurs.

Hepatic Impairment: No safety data is available for use in patients with Child-Pugh C hepatic impairment.

Should be taken on an empty stomach. May be taken with a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.

Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of Sorafenib. Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.

Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.

Pregnancy category D There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

There is no specific treatment for Sorafenib overdose. The highest dose of Sorafenib studied clinically is 800 mg twice daily. The adverse reactions observed at this dose were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, Sorafenib should be withheld and supportive care instituted.

Store at 25° C.

Amlexanox is indicated for the treatment of aphthous ulcers.

The mechanism of action by which Amlexanox accelerates healing of aphthous ulcers is unknown. In vitro studies have demonstrated Amlexanox to be a potent inhibitor of the formation and release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils and mononuclear cells. Given orally to animals, Amlexanox has demonstrated anti-allergic and anti-inflammatory activities and has been shown to suppress both immediate and delayed-type hypersensitivity reactions. The relevance of these activities of Amlexanox to its effects on aphthous ulcers has not been established. After a single oral application of 100 mg of paste (5 mg Amlexanox), maximal serum levels are observed at 2.4 hours. Most of the systemic absorption of Amlexanox is via the gastrointestinal tract and the amount absorbed directly through the active ulcer is not a significant portion of the applied dose. The half-life for elimination was 3.5 +/- 1.1 hours in healthy individuals.

Adverse reactions reported by 1-2% of patients were transient pain, stinging and/or burning at the site of application. Infrequent (<1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea.

Amlexanox oral paste is contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients in the formulation.

Wash hands immediately after applying Amlexanox oral paste directly to ulcers with the finger tips. In the event that a rash or contact mucositis occurs, discontinue use.

US FDA pregnancy category B. Teratology studies were performed with animals at doses up to two hundred and six hundred times, respectively, the projected human daily dose. No adverse fetal effects were observed. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering Amlexanox oral paste to a nursing woman.

Pediatric Use: Safety and effectiveness of Amlexanox oral paste in pediatric patients have not been established.

Ingestion of a full tube of 5 grams of paste would result in systemic exposure well below the maximum nontoxic dose of Amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.

Store in a cool & dry place. Protect from light. Keep out of reach of the children

Betamethasone & Combined preparations

Betamethasone Dipropionate is a potent topically-active corticosteroid producing prompt, marked and prolonged anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, without curing the underlying condition. These effects can be enhanced under occlusive conditions due to increased penetration of stratum corneum (by approximately a factor of 10).

Calcipotriol is a non-steroidal antipsoriatic agent, derived from vitamin D. Calcipotriol exhibits a vitamin D-like effect by competing for the 1,25(OH)₂D₃ receptor. Calcipotriol is as potent as 1,25(OH)₂D₃, the naturally occurring active form of vitamin D, in regulating cell proliferation and cell differentiation, but much less active than 1,25(OH)₂D₃ in its effect on calcium metabolism. Calcipotriol induces differentiation and suppresses proliferation (without any evidence of a cytotoxic effect) of keratinocytes, thus reversing the abnormal keratinocyte changes in psoriasis. The therapeutic goal envisaged with Calcipotriol is thus a normalization of epidermal growth.

Ointment: This Ointment is indicated for topical use only. The phototoxic effects have not been studied in psoriasis patients. All psoriasis-affected areas treated with this Ointment should be, where possible, protected from direct sunlight and UV-light with items of clothing.

• Adults: This ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 gm. The maximum recommended weekly dose of ointment is 100 gm/week. The treated area should not be more than 30% of the body surface. The use of this ointment should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods with Calcipotriol used alone for one month between periods of use of this ointment as needed.
• Children: This ointment is not recommended for use in children and adolescents below the age of 18 years.

Topical Suspension: Apply required quantity of spray of Topical Suspension once daily to the affected areas and gently rub in using the tips of the fingers. Treatment may be continued for up to 8 weeks. Treatment may be discontinued earlier, if symptoms are cleared. The maximum weekly dose should not exceed 100 gm. Shake before use. This Topical Suspension is not for oral, ophthalmic or intravaginal use.

The most common adverse reactions are folliculitis and burning sensation of skin.

Betamethasone and Calcipotriol containing preparation is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It is also contraindicated in patients with known disorders of calcium metabolism. Patients with severe renal insufficiency or severe hepatic disorders are also contraindicated.

Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize. Topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and unmask latent diabetes. Rate of adrenal suppression increased with treatment duration. Systemic absorption may require evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption. Local adverse reactions may include atrophy, striae, irritation, acne form eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids. Use is not recommended on face, axillae, groin or where atrophy is present. Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.

Additive adverse effects when used with other steroids.

There are no adequate and well-controlled studies in pregnant women. Ointment or suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriol and Betamethasone ointment or suspension is administered to a nursing woman.

Store in a cool (below 25ºC) & dry place & protect from light. Do not refrigerate. Keep out of the reach of children.

Acitretin is indicated in severe extensive psoriasis which is resistant to other forms of therapy, palmo-plantar pustular psoriasis, severe congenital ichthyosis, severe Darier’s disease (keratosis follicularis).

Oral Retinoid preparations

Acitretin is a retinoid, an aromatic analogue of vitamin A. The mechanism of action of acitretin is unknown, however, evidence exists for a wide range of actions at various cellular and subcellular levels. These include regulation of RNA/DNA synthesis, modulation of factors which influence epidermal proliferation, modification of glycoprotein synthesis and modulation of the immune response. Whatever the exact mechanism of action, the most prominent effect of acitretin is a modulation of cellular differentiation in the epidermis which re-establishes a more normal pattern of cell growth.

Adult and elderly: Initial daily dose should be 25 mg or 30 mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. In general, a daily dosage of 25-50 mg taken for a further 6 to 8 weeks to achieve optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75 mg/day.

In patients with Darier’s disease a starting dose of 10 mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated as only limited clinical data are available on patients treated beyond this length of time.

Children: The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day.

Adverse effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Acitretin are dose-related and are usually well-tolerated at the recommended dosages. However, the toxic dose of Acitretin is close to the therapeutic dose and most patients experience some side-effects during theinitial period whilst dosage is being adjusted. The skin and mucous membranes are most commonly affected. An initial worsening of psoriasis symptoms issometimes seen at the beginning of the treatment period.

Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment. The use of Acitretin is contra-indicated in women who are breast feeding.Acitretin is contraindicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values. Concomitant administration of Acitretin with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A. Acitretin is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. Patients with rare glucose-galactosemalabsorption should not take this medicine.

The risk of giving birth to a deformed child is exceptionally high if Acitretin is taken before or during pregnancy, no matter for how long or at what dosage. Women of childbearing potential must not receive blood from patients being treated with acitretin. Donation of blood by a patient being treated with acitretin is prohibited during and for two years after completion of treatment with acitretin. The effects of UV light are enhanced by retinoid therapy; therefore patients should avoid excessive exposure to sunlight. Hepatic function should be checked before starting treatment with Acitretin, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. Serum cholesterol and serum triglycerides (fasting values) must be monitored before starting treatment, one month after the commencement and then every 3 months during treatment, especially in high-risk patients and during long-term treatment. Retinoids can alter glucose tolerance, blood sugar levels should therefore be checked. Patients should be warned of the possibility of alopecia. Decreased night vision has been reported with acitretin therapy. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue acitretin immediately.

Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. Concomitant administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. In concurrent treatment with phenytoin, it must be remembered that Acitretin partially reduces the protein binding of phenytoin. Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy, Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Acitretin is contraindicated in pregnant women or nursing mother. It is highly teratogenic. Its use is contraindicated in women who might become pregnant during or within 2 years of the cessation of treatment.

Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Acitretin would probably be similar. Specific treatment is unnecessary because of the low acute toxicity of the preparation.

Store in a cool & dry place, protected from light. Do not store above 25°C.

Acitretin is indicated in severe extensive psoriasis which is resistant to other forms of therapy, palmo-plantar pustular psoriasis, severe congenital ichthyosis, severe Darier’s disease (keratosis follicularis).

Oral Retinoid preparations

Acitretin is a retinoid, an aromatic analogue of vitamin A. The mechanism of action of acitretin is unknown, however, evidence exists for a wide range of actions at various cellular and subcellular levels. These include regulation of RNA/DNA synthesis, modulation of factors which influence epidermal proliferation, modification of glycoprotein synthesis and modulation of the immune response. Whatever the exact mechanism of action, the most prominent effect of acitretin is a modulation of cellular differentiation in the epidermis which re-establishes a more normal pattern of cell growth.

Adult and elderly: Initial daily dose should be 25 mg or 30 mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. In general, a daily dosage of 25-50 mg taken for a further 6 to 8 weeks to achieve optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75 mg/day.

In patients with Darier’s disease a starting dose of 10 mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated as only limited clinical data are available on patients treated beyond this length of time.

Children: The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day.

Adverse effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Acitretin are dose-related and are usually well-tolerated at the recommended dosages. However, the toxic dose of Acitretin is close to the therapeutic dose and most patients experience some side-effects during theinitial period whilst dosage is being adjusted. The skin and mucous membranes are most commonly affected. An initial worsening of psoriasis symptoms issometimes seen at the beginning of the treatment period.

Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment. The use of Acitretin is contra-indicated in women who are breast feeding.Acitretin is contraindicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values. Concomitant administration of Acitretin with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A. Acitretin is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. Patients with rare glucose-galactosemalabsorption should not take this medicine.

The risk of giving birth to a deformed child is exceptionally high if Acitretin is taken before or during pregnancy, no matter for how long or at what dosage. Women of childbearing potential must not receive blood from patients being treated with acitretin. Donation of blood by a patient being treated with acitretin is prohibited during and for two years after completion of treatment with acitretin. The effects of UV light are enhanced by retinoid therapy; therefore patients should avoid excessive exposure to sunlight. Hepatic function should be checked before starting treatment with Acitretin, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. Serum cholesterol and serum triglycerides (fasting values) must be monitored before starting treatment, one month after the commencement and then every 3 months during treatment, especially in high-risk patients and during long-term treatment. Retinoids can alter glucose tolerance, blood sugar levels should therefore be checked. Patients should be warned of the possibility of alopecia. Decreased night vision has been reported with acitretin therapy. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue acitretin immediately.

Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. Concomitant administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. In concurrent treatment with phenytoin, it must be remembered that Acitretin partially reduces the protein binding of phenytoin. Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy, Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Acitretin is contraindicated in pregnant women or nursing mother. It is highly teratogenic. Its use is contraindicated in women who might become pregnant during or within 2 years of the cessation of treatment.

Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Acitretin would probably be similar. Specific treatment is unnecessary because of the low acute toxicity of the preparation.

Store in a cool & dry place, protected from light. Do not store above 25°C.

This Scalp Ointment has mild, antipruritic, antiseptic and keratolytic properties. It is indicated in the treatment of common scaly skin disorders of the scalp such as psoriasis, eczema, seborrhoeic dermatitis and dandruff.

Coal-tar preparations

Coal Tar has antipruritic, keratoplastic and keratolytic properties. It slows down excessive epidermal cell turnover and is often used topically either alone or in combination with other drugs (e.g. salicyclic acid, sulfur) in conditions such as dandruff, seborrheic dermatitis or psoriasis.

Precipitated Sulpher is converted to hydrogen sulfide (H2S) through reduction, partly by bacteria. H2S kills bacteria (possibly including Propionibacterium acnes which plays a role in acne) fungi, and parasites such as scabies mites.

Salicylic Acid has a potent keratolytic action and a slight antiseptic action when applied topically. It softens and destroys the stratum corneum by increasing endogenous hydration which causes the horny layer of the skin to swell, soften, and then desquamate. At high concentrations, salicylic acid has a caustic effect. It also possesses weak antifungal and antibacterial activity.

Adults, children over 12 years and the elderly: Apply to the affected areas of the scalp and remove after one hour using warm water and shampoo. Repeat the process daily for three to seven days until control has been obtained. With mild scaliness use intermittently as necessary.

Children 6-12 years: To be used under medical supervision only.

Children under 6 years: Not recommended.

Coal Tar ointment is for external use only, ie applied onto the skin. Follow your doctor’s instructions and check the leaflet on how to use. In severe scaly scalp conditions it is usually necessary to apply Coal Tar ointment daily for 3-7 days until control has been obtained. With mild scaliness use intermittently as necessary, eg once a week.

• Pierce the tube membrane by inverting the cap. This scalp applicator to the threaded portion of the tube.
• Part the hair and apply a thin ribbon of Coal Tar ointment to the affected areas of the scalp. Take care to avoid contact with the eyes. Gently rub in the ointment and leave in contact with scalp for approximately one hour. Wash the hands immediately afterwards.
• After One hour remove the ointment by showering or rinsing with warm water. If after the first week there is no improvement or after 4 weeks symptoms persist, consult your doctor. If you accidentally get some into your eyes wash it out immediately with plenty of cold tap water. If irritation of the eyes develops consult your doctor or pharmacist.

Coal Ta ointment may occasionally cause irritation of the skin, inflammation of the hair follicles and rarely photosensitivity of the skin.

Cool tar Scalp Ointment is contraindicated in patients known to be sensitive to sulfur, salicylates, coal tar or in the presence of local infections. Warnings & Precautions: Do not use if the tube membrane is already perforated. Avoid contact with the eyes and wash your hands. Discontinue use if irritation develops. If symptoms persist after four weeks, consult your doctor.

To be used at the discretion of the physician.

Overdose is extremely unlikely If necessary, remove medication by washing with warm water and treat symptomatically.

Store in a cool and dry place, protected from light.

Coal Tar Cream is indicated for psoriasis. Soritar Cream has a keratoplastic and antipruritic effect in psoriasis.

Coal-tar preparations

Coal tar has antipruritic, keratoplastic and keratolytic properties. It slows down excessive epidermal cell turnover and is often used topically either alone or in combination with other drugs (e.g. salicyclic acid, sulfur) in conditions such as dandruff, seborrheic dermatitis or psoriasis.

Adults and children over 12 years of age: Ensure that the lesions are clean. Apply a thin layer of Coal Tar Cream two or three times a day on to the affected areas massage in gently and leave to dry.

For young children under 12 years of age and the elderly: The emulsion may be diluted by mixing it with a few drops of cooled freshly boiled in the palm of the hand.

For topical application only.

Skin and subcutaneous tissue disorders: Skin irritation, photosensitivity of the skin, Coal Tar Cream may cause acne-like eruptions of the skin. There is an increased risk of skin cancer in psoriatic patients treated with a combination of Coal Tar Cream and UVB radiation has been reported. However epidemiological studies of patients treated with Coal Tar Cream on its own are inconclusive. The risk of toxicity should be taken into account when considering the prescribing this product for the patient.

Coal Tar should not be used when a patient has known sensitivity to Coal Tar or any of the other ingredients. If you have folliculitis and acne vulgaris. Coal Tar Cream should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or allergy to sunlight. Coal Tar Cream should not be applied to inflamed or broken skin. Warnings and precautions: For topical administration only. Coal Tar Cream may cause skin irritation, should this occur the treatment should be reviewed and if necessary discontinued. Coal Tar enhances photosensitivity of the skin after applying Coal Tar Cream exposure to direct sunlight should be avoided. Use with care near the eyes and mucous membranes. If any emulsion should accidentally enter the eye, flush with normal saline solution or water. Do not apply to genital and rectal areas. Apply with caution to the face do not get in the eyes. Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic reactions that might be cause a delayed reaction.

There is no direct evidence of the safety in pregnant and lactating mother. Coal tar preparations have been in use for many years without apparent ill-consequence. No harmful effects on the health of the child is anticipated with the proper use of coal tar. However it is recommended that the use of coal tar in pregnancy and lactation is restricted to intermittent use in low concentrations on a small percentage of body’s surface, use during the first trimester be avoided.

There is no evidence that an overdose of topical Coal Tar Cream would be harmful other than a hypersensitivity to coal tar. Ingestion of Coal Tar Cream may require gastric lavage depending on the quantity taken and should be treated symptomatically.

Store in a cool and dry place, protected from light.

Acitretin is indicated in severe extensive psoriasis which is resistant to other forms of therapy, palmo-plantar pustular psoriasis, severe congenital ichthyosis, severe Darier’s disease (keratosis follicularis).

Oral Retinoid preparations

Acitretin is a retinoid, an aromatic analogue of vitamin A. The mechanism of action of acitretin is unknown, however, evidence exists for a wide range of actions at various cellular and subcellular levels. These include regulation of RNA/DNA synthesis, modulation of factors which influence epidermal proliferation, modification of glycoprotein synthesis and modulation of the immune response. Whatever the exact mechanism of action, the most prominent effect of acitretin is a modulation of cellular differentiation in the epidermis which re-establishes a more normal pattern of cell growth.

Adult and elderly: Initial daily dose should be 25 mg or 30 mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. In general, a daily dosage of 25-50 mg taken for a further 6 to 8 weeks to achieve optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75 mg/day.

In patients with Darier’s disease a starting dose of 10 mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated as only limited clinical data are available on patients treated beyond this length of time.

Children: The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day.

Adverse effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Acitretin are dose-related and are usually well-tolerated at the recommended dosages. However, the toxic dose of Acitretin is close to the therapeutic dose and most patients experience some side-effects during theinitial period whilst dosage is being adjusted. The skin and mucous membranes are most commonly affected. An initial worsening of psoriasis symptoms issometimes seen at the beginning of the treatment period.

Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment. The use of Acitretin is contra-indicated in women who are breast feeding.Acitretin is contraindicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values. Concomitant administration of Acitretin with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A. Acitretin is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. Patients with rare glucose-galactosemalabsorption should not take this medicine.

The risk of giving birth to a deformed child is exceptionally high if Acitretin is taken before or during pregnancy, no matter for how long or at what dosage. Women of childbearing potential must not receive blood from patients being treated with acitretin. Donation of blood by a patient being treated with acitretin is prohibited during and for two years after completion of treatment with acitretin. The effects of UV light are enhanced by retinoid therapy; therefore patients should avoid excessive exposure to sunlight. Hepatic function should be checked before starting treatment with Acitretin, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. Serum cholesterol and serum triglycerides (fasting values) must be monitored before starting treatment, one month after the commencement and then every 3 months during treatment, especially in high-risk patients and during long-term treatment. Retinoids can alter glucose tolerance, blood sugar levels should therefore be checked. Patients should be warned of the possibility of alopecia. Decreased night vision has been reported with acitretin therapy. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue acitretin immediately.

Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. Concomitant administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. In concurrent treatment with phenytoin, it must be remembered that Acitretin partially reduces the protein binding of phenytoin. Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy, Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Acitretin is contraindicated in pregnant women or nursing mother. It is highly teratogenic. Its use is contraindicated in women who might become pregnant during or within 2 years of the cessation of treatment.

Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Acitretin would probably be similar. Specific treatment is unnecessary because of the low acute toxicity of the preparation.

Store in a cool & dry place, protected from light. Do not store above 25°C.

Acitretin is indicated in severe extensive psoriasis which is resistant to other forms of therapy, palmo-plantar pustular psoriasis, severe congenital ichthyosis, severe Darier’s disease (keratosis follicularis).

Oral Retinoid preparations

Acitretin is a retinoid, an aromatic analogue of vitamin A. The mechanism of action of acitretin is unknown, however, evidence exists for a wide range of actions at various cellular and subcellular levels. These include regulation of RNA/DNA synthesis, modulation of factors which influence epidermal proliferation, modification of glycoprotein synthesis and modulation of the immune response. Whatever the exact mechanism of action, the most prominent effect of acitretin is a modulation of cellular differentiation in the epidermis which re-establishes a more normal pattern of cell growth.

Adult and elderly: Initial daily dose should be 25 mg or 30 mg for 2 to 4 weeks. After this initial treatment period the involved areas of the skin should show a marked response and/or side-effects should be apparent. In general, a daily dosage of 25-50 mg taken for a further 6 to 8 weeks to achieve optimal therapeutic results. However, it may be necessary in some cases to increase the dose up to a maximum of 75 mg/day.

In patients with Darier’s disease a starting dose of 10 mg may be appropriate. The dose should be increased cautiously as isomorphic reactions may occur. Patients with severe congenital ichthyosis and severe Darier’s disease may require therapy beyond 3 months. The lowest effective dosage, not exceeding 50mg/day, should be given. Continuous use beyond 6 months is contra-indicated as only limited clinical data are available on patients treated beyond this length of time.

Children: The daily dosage is about 0.5mg/kg. Higher doses (up to 1mg/kg daily) may be necessary in some cases for limited periods, but only up to a maximum of 35 mg/day.

Adverse effects are seen in most patients receiving acitretin. Most of the clinical side-effects of Acitretin are dose-related and are usually well-tolerated at the recommended dosages. However, the toxic dose of Acitretin is close to the therapeutic dose and most patients experience some side-effects during theinitial period whilst dosage is being adjusted. The skin and mucous membranes are most commonly affected. An initial worsening of psoriasis symptoms issometimes seen at the beginning of the treatment period.

Acitretin is highly teratogenic and must not be used by women who are pregnant. The same applies to women of childbearing potential unless strict contraception is practiced 4 weeks before, during and for 2 years after treatment. The use of Acitretin is contra-indicated in women who are breast feeding.Acitretin is contraindicated in patients with severe hepatic or renal impairment and in patients with chronic abnormally elevated blood lipid values. Concomitant administration of Acitretin with other retinoids or Vitamin A is contra-indicated due to the risk of hypervitaminosis A. Acitretin is contra-indicated in cases of hypersensitivity to the preparation (acitretin or excipients) or to other retinoids. Patients with rare glucose-galactosemalabsorption should not take this medicine.

The risk of giving birth to a deformed child is exceptionally high if Acitretin is taken before or during pregnancy, no matter for how long or at what dosage. Women of childbearing potential must not receive blood from patients being treated with acitretin. Donation of blood by a patient being treated with acitretin is prohibited during and for two years after completion of treatment with acitretin. The effects of UV light are enhanced by retinoid therapy; therefore patients should avoid excessive exposure to sunlight. Hepatic function should be checked before starting treatment with Acitretin, every 1-2 weeks for the first 2 months after commencement and then every 3 months during treatment. Serum cholesterol and serum triglycerides (fasting values) must be monitored before starting treatment, one month after the commencement and then every 3 months during treatment, especially in high-risk patients and during long-term treatment. Retinoids can alter glucose tolerance, blood sugar levels should therefore be checked. Patients should be warned of the possibility of alopecia. Decreased night vision has been reported with acitretin therapy. Patients with severe headache, nausea, vomiting, and visual disturbances should discontinue acitretin immediately.

Existing data suggests that concurrent intake of acitretin with ethanol led to the formation of etretinate. Concomitant administration of methotrexate, tetracyclines or vitamin A and other retinoids with acitretin is contraindicated. In concurrent treatment with phenytoin, it must be remembered that Acitretin partially reduces the protein binding of phenytoin. Low dose progesterone-only products (minipills) may be an inadequate method of contraception during acitretin therapy, Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.

Acitretin is contraindicated in pregnant women or nursing mother. It is highly teratogenic. Its use is contraindicated in women who might become pregnant during or within 2 years of the cessation of treatment.

Manifestations of acute Vitamin A toxicity include severe headache, vertigo, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Acitretin would probably be similar. Specific treatment is unnecessary because of the low acute toxicity of the preparation.

Store in a cool & dry place, protected from light. Do not store above 25°C.

Tazarotene is used to treat plaque psoriasis of the skin. It also works to treat acne on the face.

Topical retinoid and related preparations

Tazarotene is a retinoid prodrug which is converted to its active form, the cognate carboxylic acid of tazarotene, by rapid deesterification in animals and man. In cell culture and in vitro models of skin, tazarotene suppresses expression of MRP8, a marker of inflammation present in the epidermis of psoriasis patients at high levels. In human keratinocyte cultures, it inhibits cornified envelope formation, whose build-up is an element of the psoriatic scale.

For psoriasis: Tazarotene cream should be applied once per day, in the evening, to psoriatic lesions, using enough (2 mg/cm²) to cover only the lesion with a thin film. If a bath or shower is taken prior to application, the skin should be dried before applying the cream. If emollients are used, they should be applied at least one hour before application of Tazarotene cream.

For acne: Cleanse the face gently. After the skin is dry, apply a thin layer (2mg/cm²) of Tazarotene cream 0.1% once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.

The most frequent adverse events reported with Tazarotene cream were limited to the skin. Those occurring in 10 to 23% of patients, in descending order, included pruritus, erythema and burning. For acne treatment, in 10 to 30% patients, it is reported desquamation, dry skin, face pain, irritation and stinging sensation.

Retinoids may cause fetal harm when administered to a pregnant woman. Tazarotene cream is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be warned to the potential risk and use adequate birth-control measures when Tazarotene cream is used.

Tazarotene cream should be applied only to the affected areas. For external use only. Avoid contact with eyes, eyelids and mouth. If contact with eyes occurs, rinse thoroughly with water. Retinoids should not be used on eczematous skin, as they may cause severe irritation. Patients must be warned to use sunscreens and protective clothing when using Tazarotene cream. Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced

Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient’s skin until the effects of such preparations subside before use of Tazarotene cream is begun. Topical steroid may be hazardous in psoriasis; careful patient supervision is important. Consider if infection spreads. Do not use near a naked flame.

Pregnancy: Tazarotene is not recommended during pregnancy. It has been shown to cause serious birth defects and problems in animals. Be sure you have discussed this with your doctor.

Nursing Mothers: It is not known whether tazarotene passes into breast milk. However, Tazarotene is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

Pediatric Use: Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of Tazarotene in children up to 12 years of age (gel) and up to 18 years of age (cream) with use in other age groups.

Elderly Use (Over 65 year): There is no specific information comparing the use of Tazarotene in the elderly with use in other age groups.

Excessive topical use cause marked redness, peeling or discomfort. Accidental oral ingestion produces similar adverse effects as those associated with excessive oral intake of Vitamin A or other retinoids. Monitor and take supportive measures as necessary.

Store at 25° C.

Oral Rehydration Salt replacement of fluid and electrolyte loss due to-

• Acute diarrhea
• Vomiting
• Dehydration

Other conditions of fluid loss or lack of intake in patients of all age groups.

Oral electrolytes preparations

This is the preparation of oral rehydration salt. It is composed of anhydrous glucose, sodium chloride, potassium chloride and sodium citrate (as dihydrate). This is a single formulation of glucose based oral rehydration salt to treat or prevent dehydration from diarrhea of any etiology, including cholera and in individuals of any age. This also prevents acidosis due to electrolyte imbalance.

Daily dose should be equivalent to patients' fluid requirement for maintenance and replenishment of losses. During this therapy, mother should not stop breastfeeding to their child and normal food should be continued in case of adults.

Children less than 2 years: After each loose stool or vomiting 50-100 mL (10 to 20 teaspoonful) of prepared this.

Children 2 to 10 years: After each loose stool or vomiting 100-200 mL (1/2 to 1 glass) of prepared oral saline.

Adult and children above 10 years: After each loose stool or vomiting 200-400 mL (1 to 2 glass) of prepared this.

Depressed renal function, severe continuing diarrhea or other critical fluid losses may need supplementation with parenteral fluids along with oral saline.

There are no known drug interactions and none well documented.

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

Anti adrenergic agent (Beta blockers)

Sotalol is a non-cardioselective beta-blocker. It increases sinus cycle length, slows heart rate, decreases AV nodal conduction and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. However, it lacks intrinsic sympathomimetic and membrane-stabilising properties.

Initially 80 mg daily in 1-2 divided doses. After ECG monitoring and measurement of corrected QT interval, arrhythmias, dose is increased gradually at intervals of 2- 3 days to usual dose of 160-320 mg daily in 2 divided doses; higher doses of 480-640 mg daily for life-threatening ventricular arrhythmias under specialist supervision.

The dosage should be reduced in renal impairment. lf creatinine clearance is >60 ml/min, recommended dose 160 mg twice daily while in those with creatinine clearance between 40 and 60 ml/ min, the dose is administered once daily. ln patients with creatnine clearance less than 40 ml/min, Sotalol is contraindicated.

The most significant adverse effects are those which are typical of its class I and class II (Cardiac action potential duration prolongation) effects.

Sotalol should not be given to patients with sinus, bradycardia, sick sinus syndrome or second or third degree AV block (unless a functional pacemaker is present); congenital or acquired long QT syndromes, torsades de pointes, uncontrolled congestive heart failure, cardiogenic shock; anaesthesia that produces myocardial depression, hypotension (except due to arrhythmia), severe peripheral circulatory disturbances, chronic obstructive airway disease or bronchial asthma, renal failure (ceratinine clearance <40mL/min) and previous evidence of hypersensitivity to Sotalol. Sotalol should not be given to patients suffering from diabetic keto-acidosis or metabolic acidosis, therapy with Sotalol can be recommenced or resumed when the metabolic condition has been corrected.

Sotalol is not for everyone with irregular heartbeats (atrial fibrillation). Sotalol is not indicated for those patients who have serious kidney problems or are on kidney dialysis, lung disease causing shortness of breath (such as asthma, chronic bronchitis or emphysema), symptoms of heart failure (such as shortness of breath when in exercise or physically active and swelling of the ankles or legs), very slow heart beat and do not have an implanted artificial pacemaker.

ln combined therapy, clonidine should not be discontinued unitil several days after withdrawal of Sotalol. Use with great caution with drugs that also prolong OT interval, e.g. disopyramide, amiodarone, Class I antiarrhythmic agents, calcium antagonists of the verapamil type or tricyclic antidepressants. Interactions also occur with phenothiazines, terfenadine, astemizole and diltiazem. Concomitant use of reserpine, guanethidine, or alpha methyldopa requires close monitoring for evidence of hypotension and/or marked bradycardia, syncope. Hypoglycemia may occur and the dosage of insulin or antidiabetic drugs may require adjustment.

Its use throughout pregnancy should be avoided unless it is absolutely necessary as it crosses the placenta and may cause foetal bardycardia. Infants should not be fed with breast milk from mothers being treated with Sotalol

Overdosage causes excessive bradycardia and hypotension; congestive heart failure, bronchospasm and hypoglycemia.

Store in a cool and dry place, protected from light.

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

• Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
• Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
• Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
• Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
• In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
• The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Reconstitution procedure of suspension-

• Step 01: Shake the bottle well to loosen the powder.
• Step 02: Add boiled and cooled water up to the water mark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.

Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

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