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Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole causes inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is either completely or partially inhibited, the cell is no longer able to construct an intact and functional cell membrane. Because ergosterol directly promotes the growth of fungal cells in a hormone‐like fashion, rapid onset of the above events leads to dose-dependent inhibition of fungal growth.

Though decreased ergosterol, due to the inhibition of lanosterol 14-demethylase (also known as CYP51) is accepted to be primarily responsible for the antimycotic properties of clotrimazole, this drug also shows other pharmacological effects. These include the inhibition of sarcoplasmic reticulum Ca²⁺ ATPase, depletion of intracellular calcium, and blocking of calcium‐dependent potassium channels and voltage‐dependent calcium channels. The action of clotrimazole on these targets accounts for other effects of this drug that are separate from its antimycotic activities.

Clotrimazole Cream: This should be thinly applied 2-3 times daily to the infected sites and rubbed in. On account of the excellent efficacy, a small amount of cream is usually sufficient for an area about the size of the palm. For the treatment to become a complete success, reliable and sufficiently long-time application of Clotrimazole Cream is important. The duration of treatment varies; it depends among other factors on the extent and localization of the disease.

Recommended duration of treatment-

• Dermatomycoses: 3-4 weeks
• Candida vulvitis and Candida balanitis: 1-2 weeks
• Erythrasma and Pityriasis Versicolor: 3 weeks (approximately)

In fungal infection of the feet, to prevent relapse, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease. After washing, the feet should be thoroughly dried (particularly spaces between the toes). Clotrimazole Cream is odorless, can be washed off and does not stain clothing.

Clotrimazole topical solution: Apply this sparingly to the affected areas and rub in gently, two or three times daily.

When applied topically, Clotrimazole is well tolerated.With external application, systemic effects are not observed. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful.

Hypersensitivity to Clotrimazole.

No information is available.

It is recommended that Clotrimazole should be used in pregnancy only when considered necessary by the physician.

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

It is a harbal ointment preparation for skin diseases for topical application. This is indicated in Wounds & burns, Dermatitis & dry skin, Anal eczema & proctitis, Leg ulcer, Boils, bruises & rashes.

Herbal and Nutraceuticals

Apply topically to the affected area 2 to 3 times daily or as directed by the physician.

Not yet known.

There is no absolute contraindication.

No restriction is known yet.

This kit is indicated for the treatment and prevention of Osteoporosis. It increases Bone Mineral Density (BMD) and reduces the incidence of vertebral fractures.

Bisphosphonate preparations

Ibandronic Acid (Ibandronate Sodium Monohydrate) is a nitrogen- containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The action of Ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

The combination of Coral Calcium and Colecalciferol is composed of Calcium Carbonate with small amounts of Magnesium and other Trace minerals. Coral Calcium ensures better absorption than Calcium of other Calcium Carbonate origin due to its chemical structure that is very similar to the composition of human bone Calcium Carbonate. Vitamin-D aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet of Ibandronic Acid 150 mg once monthly on the same date of each month is recommended. To maximize clinical benefit of Ibandronic acid, two tablets of Calcium 500 mg and Vitamin D3 200 IU per day are usually recommended in divided dosage or as directed by the physician.

Day 1: Take the Ibandronic Acid tablet on an empty stomach at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation including Calcium, Antacid and/or Vitamins

• Swallow tablet whole with a glass of plain water while standing or sitting in an upright position
• Avoid lying down for 60 minutes
• Do not chew or suck the tablet

Day 2-31: One tablet of Calcium and Vitamin D should be taken at the morning and at the evening after meal

• Tablets should be taken in order as directed on the blister strip for ease of dose tracking.

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

Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia etc.

Calcium & Vitamin D3: Most common side effects are flatulence, diarrhea, constipation, upper GI discomfort etc. Hypercalciuria and hypercalcemia due to prolong use has rarely been reported.

Ibandronic Acid is contraindicated in conditions like: abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 60 minutes, Hypocalcemia, known hypersensitivity to Ibandronic Acid.

Calcium & Vitamin D3: Hypersensitivity to any of the component of this preparation. It is also contraindicated in case of hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiencies, concomitant Digoxin therapy (requires careful monitoring of serum calcium level), renal calculi and Zollinger Ellison syndrome.

Ibandronic Acid:

• Upper Gastrointestinal Adverse Reactions: Ibandronic acid like other bisphosphonates administered orally may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects, caution should be used when Ibandronic acid is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
• Hypocalcaemia and Mineral Metabolism: Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy.
• Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic acid and other bisphosphonates.
• Jaw Osteonecrosis: Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses.

Calcium and Vitamin-D: In mild hypercalciuria reduction of dose is sufficient to return to normal serum Calcium concentration. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment patients and also in case of long term use. Patients with renal stone or with such previous history should be recommended to increase their fluid intake.

Ibandronic Acid: Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron), including milk, food, and antacids are likely to interfere with absorption of Ibandronate. It is also found to interact with H2 blockers such as Ranitidine in several clinical trials..

Calcium (Coral) and Vitamin-D: Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours’ time should be allowed between ingestion of these medications. Thiazide diuretics reduce the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D. Concomitant intake of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. This kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Nursing mother: It is not known whether this kit is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this kit is administered to a nursing woman.

No specific information is available on the treatment of over dosage of Ibandronic acid. However, based on knowledge of this class of compounds, oral over dosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events.

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

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Specific mineral & vitamin combined preparations

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

This can be given to pregnant and lactating mothers as per recommendation of physician.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

This is indicated for the treatment & prevention of osteoporosis, osteomalacia, tetany, hypoparathyroidism, disorders of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood diet, rickets, pregnancy & lactation, elderly patients. Other indications include pancreatitis, phosphate binder in chronic renal failure etc.

Specific mineral & vitamin combined preparations

This is a Calcium and Vitamin D3 preparation where Calcium Carbonate is sourced from coral origin. The Calcium Carbonate from Coral has a chemical structure that is very similar to the composition of human bone. Coral Calcium is similar to other sources but ensures better absorption. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet once or twice daily with plenty of water or as directed by the physician. Taking in full stomach ensures better absorption.

Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.

Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastases, severe renal insufficiency, severe hypercalciuria, renal calculi etc.

In presence of mild hypercalciuria, careful monitoring with reduction of dose may be needed. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment and also in case of long-term use. Patients with renal stones or with such previous history should also take precautions.

Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours time should be allowed between ingestion of these medications. Thiazide diuretics reduces the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

This can be given to pregnant and lactating mothers as per recommendation of physician.

At high doses it may result in nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.

Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.

Drugs acting on the Uterus, Prostaglandin analogues

Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.

Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.

Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).

Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.

The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.

Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).

Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.

Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.

Lactation-

• Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
• Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.

Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.

Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.

Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.

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

Magaldrate is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux, hiatal hernia and flatulence. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary.

Antacids, Anti-dyspeptic/Carminatives

Magaldrate is a hydroxymagnesium aluminate complex that is converted rapidly in gastric acid to Mg(OH)₂ and Al(OH)₃, which are absorbed poorly and thus provide a sustained antacid effect

Tablet: 1-3 tablets, after meals and at bed time or as directed by the physician.

Syrup: 2 to 3 teaspoonful, 3 or 4 times daily, half to one hour after or before meal and at bedtime

Constipation and diarrhea may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal function

Pregnant women: Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage.

Lactating mother: Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

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

This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

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

This is indicated to prevent pregnancy. Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets), the chance of becoming pregnant is very low.

Oral Contraceptive preparations

This pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually, it will start on day 2-3 after the last tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.

Starting your first pack of this tablet-

• When no hormonal contraceptive has been used in the past month: Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the day's in order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet taking in the first cycle.
• When changing from another combined Pill: You can start taking this tablet the day after you take the last tablet from your present Pill pack (this means no tablet free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill).
• When changing from a progestagen-only Pill (minipill): You can stop taking the minipill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.
• When changing from an injectable or implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
• After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet, you should discuss this first with your doctor.
• After a miscarriage or an abortion: Your doctor will advise you.

If too many this tablet are taken (overdose): There have been no reports of serious harmful effects from taking too many this tablets at one time. If you have taken several tablets at a time, you may have nausea, vomiting or vaginal bleeding. If you discover that a child has taken this tablet, ask your doctor for advice.

When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.

If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.

If you forget tablets:

• If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.
• If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore you should follow the rules given below.

More than one tablet forgotten in a pack: Ask your doctor for advice.

1 tablet missed in week 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.

1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.

1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or

Stop taking tablets from your current pack, have a tabletfree break of 7 days or less (also count the day you
missed your tablet) and continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.

If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.

you vomit: If you vomit within 3 to 4 hours after taking your this tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.

you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 day tablet-free break.

you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.

You have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.

you have missed a period: If you have taken all of your tablets at the right time, and you have not vomited, or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.

Possible side effects: The following side effects have been reported by users of the Pill, although they need not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time.

• breast tenderness, pain and secretion;
• headache;
• changes in sexual drive; depressive moods;
• contact lens intolerance;
• nausea, vomiting and feeling sick;
• changes in vaginal secretion;
• various skin reactions;
• fluid retention;
• changes in body weight;
• hypersensitivity reactions.

Do not use the combined Pill if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use this tablet. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.

• If you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body.
• If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
• If you have diabetes mellitus with blood vessel damage.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have had cancer of the breast or the genital organs.
• If you have or have had a benign or malignant tumour in the liver.
• If you have any unexplained vaginal bleeding.
• If you are pregnant or think you might be pregnant.
• If you are allergic to any of the ingredients of this tablet.

If any of these conditions appear for the first time while using the Pill, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures.

Before you start to use this tablet: If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use this tablet

• you smoke;
• you have diabetes;
• you are overweight;
• you have high blood pressure;
• you have a heart valve disorder or a certain heart rhythm disorder;
• you have an inflammation of your veins (superficial phlebitis);
• you have varicose veins;
• anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
• you suffer from migraine;
• you suffer from epilepsy;
• you or someone in your immediate family have or had high blood levels of cholesterol or triglycerides (fatty substances);
• anyone in your immediate family has had breast cancer;
• you have liver or gallbladder disease;
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus eryhematosus (SLE; a disease affecting the skin all over the body);
• you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys);
• you have sickle cell disease;
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face): if so, avoid too much exposure to the sun or ultraviolet radiation.

If any of the above conditions appear for the first time, recur or worsen while using the Pill, you should contact your doctor.

The Pill and Thrombosis: A thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "Pulmonary embolism." Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill-users than in non-users, but it is not as high as the risk during pregnancy.

Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.

Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.

The risk of having a heart attack or stroke increases, as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.

If you develop high blood pressure while using the Pill, you may be told to stop using it.

The risk of having a deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet. If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.

The Pill and cancer: Breast cancer has been diagnosed, slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier. In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your stomach.

Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behaviour and other factors.

The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (eg. primidone, phenytoin, barbiturates) and tuberculosis (eg. rifampicin); and antibiotics (eg. ampcillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.

The Pill and Ability to Drive: There are no observed effects.

The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.

The Pill and Pregnancy: This tablet must not be used by women who are pregnant, or who think they may be pregnant.

Store in a cool & dry place in between 2-25° C, protect from light. Keep out of the reach of children.

Contraception, Oral contraceptives

Oral Contraceptive preparations

Antacids

This is the combination of Sodium Alginate and Potassium Bicarbonate. Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Sodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the esophagus. This relieves the symptoms of reflux such as heartburn. The mode of action of this is physical and does not depend on absorption into the systemic circulation. The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.

Tablet:

• Adults and children over 12 years: 1-2 tablets 3-4 times daily, after meals and before bedtime.
• Children 6-12 years: ½-1 tablet 3-4 times daily, after meals and before bedtime.

Suspension:

• Adults and children 12 years and above: 5-10 ml (1-2 teaspoonfuls) 3-4 times daily, after meals and before bedtime.
• Children 2-12 years: 2.5-5ml (½-1 teaspoonful) 3-4 times daily, after meals and before bedtime.

Use in children: This is not recommended under 2 years of age.
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.

In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.

Sodium alginate and potassium bicarbonate is contraindicated in patients with known hypersensitivity to these.

Sodium Alginate and Potassium Bicarbonate should be prescribed with caution in patients with renal impairment and congestive cardiac failure. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.

A time interval of 2 hours should be considered between this intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.

This combination (Sodium Alginate and Potassium Bicarbonate) can be used during pregnancy, if clinically needed. No known effect on breast-fed infants. This combination can be used during breastfeeding.

Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.

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

Ketotifen is indicated in the following conditions-

• For the prophylactic treatment of bronchial asthma.
• Symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
• For alleviating the complications of itching, pain and tenderness associated with neurofibroma.
• Symptomatic treatment of allergy such as hayfever, urticaria.

Cromoglycate & related drugs

Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen possesses marked anti-anaphylactic properties and is effective in preventing an asthmatic attacks. Ketotifen exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties. Experimental investigations in asthmatic subjects have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamines were ineffective in those tests. The effectiveness of Ketotifen has been studied in long-term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completely freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible. The prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Adults: 1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.

Children above 3 years: 1 mg twice daily with food. Patients known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.

Use in elderly: Same as adult dose or as advised by the physician.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast feeding can not be given.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patient. If inter current infection occurs, Ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Ketotifen, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of Ketotifen treatment on the individual is known. Patients should be advised to avoid alcoholic drinks. Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.

Ketotifen may potentiate the effects of sedatives, hypnotics, antihistamines and alcohols. A reversible fall in the platelet count has been observed in a few patients receiving Tifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.

Although there is no evidence of any teratogenic effect, Ketotifen in pregnancy and lactation is not recommended.

The reported features of overdosage include confusion, drowsiness, headache, bradycardia, respiratory depression etc. should be watched for. Elimination of the drug with gastric lavage or emessis is recommended. Otherwise, general supportive treatment is all that is required shall be instituted.

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

Ketotifen eye drop is indicated for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and eyelids) of allergic conjunctivitis including vernal kerato-conjunctivitis, vernal-keratitis, blepharitis, blepharo-conjunctivitis, and giant papillary conjunctivitis.

Ophthalmic Non-Steroid drugs

Ketotifen is a potent anti-allergic substance possessing a powerful and sustained non-competitive histamine (H1) receptor blocking property. Ketotifen inhibits the release of mediators (e.g histamine, leukotrienes and prostaglandins) from cells responsible for type-(I) allergic reactions. Ketotifen also stabilizes mast cells, decreases chemotaxis, activation of degranulation of eosinophils.

Adults and children 3 years and older: 1 drop in the affected eye(s) twice daily, every 8-12 hours, not more than twice per day.

Children under 3 years of age: Consult with a doctor.

Common side effects are burning, stinging, punctate corneal epithelial erosion, Blurring of vision upon drug instillation, dry eyes, eyelid disorder, conjunctivitis, eye pain, photophobia, subconjunctival haemorrhage.

Hypersensitivity to Ketotifen or any of the components

The formulation of Ketotifen 0.025% eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore this eye drops should not be instilled while the patient is wearing lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.

If Ketotifen eye drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

There are no adequate data from the use of ketotifen eye drops in pregnant women. Systemic levels after ocular administration are much lower than after oral use. Caution should be exercised when prescribing to pregnant women. Although animal data following oral administration show excretion into breast milk, topical administration to humans is unlikely to produce detectable quantities in breast milk. ketotifen 0.25% eye drops can be used during lactation.

No case of overdose has been reported. Oral ingestion of the contents of a 5 ml bottle would be equivalent to 1.25 mg of Ketotifen which is 60% of a recommended oral daily dose for a 3 years old child. Clinical results have shown no serious signs or symptoms after oral ingestion of up to 20 mg of Ketotifen.

Store in a cool and dry place protected from light and moisture. Keep out of reach of children. Do not touch the dropper tip to any surface since this may contaminate the solution. Do not use after 30 days of first opening.

Indicated for the treatment of osteoarthritis of knee, hip, spine, hand, and other locations as a dietary supplement. It is also beneficial in rheumatoid arthritis, sport injuries, migraine, different skin problems (e.g., psoriasis), vascular complications (e. g., atherosclerosis), kidney stones, and inflammatory bowel disease (e.g., ulcerative colitis, leaky gut syndrome).

Stimulation of Cartilage formation

Glucosamine is a natural amino-sugar, produced by the body and found in certain foods. It is the most fundamental building block required for biosynthesis of glycosaminoglycans (GAGs) like Hyaluronic Acid, Keratan Sulfate, and Chondroitin Sulfate. GAGs binds with protein and form proteoglycans, the essential building block of articular cartilage. When cartilage in a joint deteriorates,Osteoarthritis develops. It also helps to form ligaments, tendon, nails, and various other connective tissues.When we take artificially synthesized Glucosamine Sulfate supplement, it increases Glucosamine level in the body, thus facilitates production and repair of cartilage. Glucosamine also activates chondrocytes in the cartilage which help produce GAGs and proteoglycans.

Chondroitin Sulfate is a glycosaminoglycan (acid muco polysaccharide) found in connective tissue, especially in the articular cartilage of all mammals. Chondroitin Sulfate supplement acts similarly as Glucosamine Sulfate, since it also provide substrate for proteoglycans. Chondroitin also protects existing healthy cartilage from premature decline by preventing the MMP (Matrix metalloproteinase) enzyme that breakdowns the proteoglycans.

Combining Glucosamine with Chondroitin Sulfate shows synergistic effect. Data supports that this combination has been shown to be very much effective in severe cases of Osteoarthritis that treats both sign and symptoms of Osteoarthritis & modifies disease progression. It prevents Osteoarthritis in case of normal adults. In Osteoarthritic pain it is as effective as NSAIDs with significantly better tolerability and clinical compliance. It is also helpful during the repair phase of musculo-skeletal soft tissue injuries such as tendon or ligament strains

250/200 mg tablet: 1 to 2 tablets, three times daily. Dose may be adjusted according to the response of the drug and body weight. Doses can be tapered after 60 days as per requirement of the individual and for cost convenience. Typical dosage recommendation, based on body weight is as follows-

• Under 54 Kg: 1000 mg Glucosamine Sulfate & 800 mg Chondroitin Sulfate per day
• 54 Kg to 91 Kg: 1500 mg Glucosamine Sulfate & 1200 mg Chondroitin Sulfate per day
• Over 91 Kg: 2000 mg Glucosamine Sulfate & 1600 mg Chondroitin Sulfate per day.

750/600 mg tablet: 1 tablet two times daily or as directed by the physician.

Safety studies with Glucosamine Sulfate & Chondroitin Sulfate show no demonstrable side effects. Rarely occurring side effects (such as, mild & reversible intestinal flatulence) are almost like placebo.

There are no known contraindications for Glucosamine and Chondroitin. But proven hypersensitivity (e. g. allergic to shellfish or sulfur) to Glucosamine and Chondroitin is a contraindication.

Patients with Diabetes Mellitus are advised to monitor blood glucose levels regularly when taking Glucosamine. No special studies were formed in patients with renal or hepatic insufficiency. The toxicological and pharmacokinetic profile of Glucosamine and Chondroitin does not indicate limitations for these patients. However, administration to patients with severe hepatic or renal insufficiency should be under appropriate medical supervision. Children should not be supplemented with Glucosamine and Chondroitin.

There have been no reports of significant drug interactions of Glucosamine and Chondroitin with Antibiotics/ Antidepressants/ Antihypertensives/ Nitrates/ Antiarrythmics/ Anxiolytics/ Hypoglycemic agents/ Antisecretives/ Antiasthmatics. Chondroitin may enhance the blood thinning effects of anticoagulants like Warfarin, Heparin.

Women who are pregnant or who could become pregnant should not supplement with Glucosamine Sulfate or Chondroitin Sulfate. Glucosamine and Chondroitin has not been studied enough to determine their effects on a developing fetus. No studies have evaluated the use of Glucosamine and Chondroitin during pregnancy or lactation. It should be taken with caution and medical advice during pregnancy and lactation.

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

Mizolastine is indicated for the symptomatic relief of the following conditions:

• Seasonal allergic rhinoconjunctivitis (hay fever)
• Perennial allergic rhinoconjunctivitis
• Urticaria

Non-sedating antihistamines

Mizolastine, a non-sedating antihistamine, blocks histamine H1-receptors on effector cells of the GI tract, blood vessels and respiratory tract. It also has mast-cell stabilising properties.

Adult and children above 12 years: The usual recommended dose is one 10 mg tablet daily.
Children below 12 years: Not recommended.

Mizolastine is well tolerated in the recommended doses. The usual side effects are dry mouth, diarrhoea, abdominal pain, nausea, drowsiness, headache, dizziness, raised liver enzymes, hypotension, tachycardia and palpitations. Bronchospasm and aggravation of asthma were reported, but in view of the high frequency of asthma in the treated patient population, a causality relationship remains uncertain.

Mizolastine is contra-indicated in patients with clinically significant cardiac disease or a history of symptomatic arrhythmias and in patients with known or suspected QT prolongation, patients with electrolyte imbalance (particularly hypokalaemia), and in those with clinically significant bradycardia. It is also contra-indicated in patients taking other drugs that decrease its metabolism, patients with significantly impaired liver function, and in patients who are hypersensitive to the drug.

Patients should be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated task.

Systemically administered Ketoconazole and Erythromycin, antiarrythmics e.g. Amiodarone moderately increase the plasma concentration of Mizolastine. This could increase the risk of arrythmias. Concurrent use of other potent inhibitor of the cytochrome P 450 3A4 enzyme e.g. Ciclosporin should be approached with caution. No potentiation of the sedation and the alteration in performance caused by alcohol with Mizolastine has been observed.

The safety of Mizolastine for use in human pregnancy has not been established. The evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri and post-natal development. Mizolastine should be avoided in pregnancy (particularly the 1 st trimester). Mizolastine is excreted into breast milk, therefore it is not recommended during lactation.

In cases of overdosage, general symptomatic surveillance with cardiac monitoring including QT interval and cardiac rhythm for at least 24 hours is recommended, along with standard measures to remove any unabsorbed drug. Studies in patients with renal insufficiency suggest that haemodialysis does not increase clearance of the drug.

Store in a cool & dry place. Protect from light. It should be kept out of the reach of children.

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglicate inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Sodium Cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators of inflammation from mast cells. Sodium Cromoglicate has no vasoconstrictor or antihistaminic activity.

For eyes: For Child and Adult: 1 to 2 drops into each eye 2 to 3 times daily.
For nose: For Child and Adult: 1 drop to each nostril 2 to 3 times daily.

Transient stinging and burning may occur after instillation of this drops. Other symptoms of local irritation have been reported rarely.

This drop is contraindicated in patient with hypersensitivity to Sodium Cromoglicate .

As this drop contains benzalkonium chloride, patients should not wear contact lenses during treatment with this drop.

No evidence of interaction with other drugs has been observed.

Sodium Cromoglicate should be used with caution during pregnancy and only if the expected benefit to the mother is greater than any possible risk to the fetus. There are no known harmful effects when this medicine is used by breastfeeding mothers.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Store at room temperature and protect from light. Any remaining contents should be discarded 4 weeks after opening. Do not touch dropper tip to any surface since this may contaminate the solution.

This is indicated in-

• Menstrual irregularity
• Dysmenorrhoea
• Amenorrhoea
• Leucorrhoea
• Metritis
• Anaemia

Herbal and Nutraceuticals

This is a uterotonic, specific for female disorders, prepared with valuable natural ingredients like Devil’s Cotton (Abroma augusta), Ashoka Tree (Saraca indica) bark, Aswagandha (Withania somnifera) etc. which acts solely on female reproductive system. This is a general nevine tonic for women. It tones up the nerves, regulates menstrual cycle and cures inflammatory pelvic disorders. It is scientifically prepared herbal syrup which regulates the development of female sexual characteristics and established healthy menstrual functions.

Menstrual irregularity and dysmenorrhoea: After menstruation till the start of next period, 2 teaspoonfuls to be taken at night
Amenorrhoea: 2 teaspoonfuls to be taken at night
Leucorrhoea: 2 teaspoonfuls to be taken at night
Metritis: 2 teaspoonfuls mixed with lukewarm water to be taken at night
Anaemia: 2 teaspoonfuls to be taken at night. In chronic cases one dose of 2 teaspoonfuls to be taken in the morning as well or as prescribed by the physician.

No significant side effect has been observed in proper dosage.

It is contraindicated for children.

Keep out of reach of the children.

Store at cool and dry place protect from light.

Homatropine Hydrobromide sterile Eye Drops is indicated for use as a mydriatic and cycloplegic agent.

Mydriatic and Cycloplegic agents

Homatropine, a tertiary amine antimuscarinic, produces dilation and loss of accommodation by blocking the response of iris sphincter muscle and the accommodative ciliary muscle to cholinergic stimulation.

Mydriasis and cycloplegia for refraction:

• Adult: Instill 1 or 2 drops of 2% solution, or 1 drop of 5% solution immediately before the procedure, repeat at 5-10 minute intervals if necessary.
• Child: Instill 1 drop of 2% soln immediately before the procedure, repeat at 10-min intervals if necessary.

Uveitis:

• Adult: Instill 1-2 drops of 2% or 5% solution bid-tid up to every 3-4 hr as needed.
• Child: 3 mth- 2 yr: instill 1 drop of 0.5% soln once daily or on alternate days. >2 yr: instill 1 drop of 1% or 2% soln bid.

Hypersensitivity may occur as conjunctivitis.

Contraindicated in patients with closed-angle glaucoma or with a narrow angle between the iris and the cornea.

Should be used with caution in patients with prostatic enlargement and in patients suffering from paralytic ileus or pyloric stenosis.

Effects may be increased by drugs with antimuscarinic effect such as; some antihistamines; phenothiazines; antipsychotics; TCAs; MAOIs or parasympathomimetics.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Matropin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Homatropine is excreted in human milk. Caution should be exercised when Matropin is administered to a nursing mother.

Use in children: Should not be used in children below the age of 3 months

Ataxia, incoherent speech, restlessness, hallucinations, disorientation, failure to recognize people and tachycardia. Psychotic reactions and behavioural disturbances (in children). SC/IM/IV Physostigmine salicylate 1-2 mg to control central and peripheral effects. Small doses of short-acting barbiturate eg. thiopentone sodium 100 mg to control excitement.

Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following:

• Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes.
• Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.

Drugs for Erectile Dysfunction

The mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes 5-HT(1A), 5-HT(1B), and 5-HT(2C) have been postulated to mediate 5-HT's modulating activity on ejaculation.

Adult (18 to 64 years of age): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours.

Dizziness, Headache, Somnolence, Tremor, Blurred vision, Tinnitus, Sinus congestion, Nausea, Diarrhea, Abdominal pain, Dry mouth, Fatigue, Insomnia, Hypertension.

Patient with bleeding disorders, epilepsy, susceptibility to angle-closure glaucoma or raised intraocular pressure. Not intended for use in women. Known CYP2D6 poor metabolisers.

CNS active medicinal products: The use of Dapoxetine in combination with CNS active medicinal products has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Dapoxetine and such medicinal products is required.

PDE5 inhibitors: Tadalafil did not affect the pharmacokinetics of Dapoxetine. Sildenafil caused slight changes in Dapoxetine pharmacokinetics, which are not expected to be clinically significant. However, Dapoxetine should be prescribed with caution in patients who use PDE5 inhibitors due to possible reduced orthostatic tolerance.

Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Dapoxetine to patients receiving daily doses of Tamsulosin did not result in changes in the pharmacokinetics of Tamsulosin. However, Dapoxetine should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.

Warfarin: There are no data evaluating the effect of chronic use of Warfarin with Dapoxetine; therefore, caution is advised when Dapoxetine is used in patients taking Warfarin chronically.

Ethanol: Concomitant use of alcohol and Dapoxetine could increase the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Dapoxetine may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine.

Dapoxetine is not indicated for use by women. It is not known either dapoxetine or its metabolites are excreted through human breast milk.

There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine with daily doses up to 240 mg. In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness. In cases of overdose, standard supportive measures should be adopted as required.

Store below 30°C. Protect from light and moisture. Keep out of reach of children