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Dicycloverine is indicated in:

• Functional bowel/irritable bowel syndrome
• Urinary incontinence secondary to unstable detrusor muscle
• Infantile colic
• GIT spasm
• Colicky abdominal pain
• Diverticulitis
• Abdominal colic

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (Not For Intravenous Use). It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.

For oral dosage forms:

• Adults:10 to 20 mg three times a day.
• Children over 6 months of age: 5 to 10 mg three times a day.

For injectable dosage form:

• Adults: Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

Children: Dose must be determined by the doctor.

Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.

Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.

Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.

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

Dicycloverine is indicated in:

• Functional bowel/irritable bowel syndrome
• Urinary incontinence secondary to unstable detrusor muscle
• Infantile colic
• GIT spasm
• Colicky abdominal pain
• Diverticulitis
• Abdominal colic

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (Not For Intravenous Use). It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.

For oral dosage forms:

• Adults:10 to 20 mg three times a day.
• Children over 6 months of age: 5 to 10 mg three times a day.

For injectable dosage form:

• Adults: Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

Children: Dose must be determined by the doctor.

Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.

Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.

Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.

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

Dicycloverine is indicated in:

• Functional bowel/irritable bowel syndrome
• Urinary incontinence secondary to unstable detrusor muscle
• Infantile colic
• GIT spasm
• Colicky abdominal pain
• Diverticulitis
• Abdominal colic

Anticholinergics (antimuscarinics)/ Anti-spasmodics

Dicycloverine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent. Chemically, it is [Bicyclohexyl-]1-carboxylic acid, 2-(diethylammo) ethyl ester, hydrochloride. Dicycloverine relieves smooth muscle spasm of the gastrointestinal tract. Dicycloverine HCl Injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (Not For Intravenous Use). It works at specific receptors, called cholinergic (or muscarinic) receptors, located on the involuntary muscle in the walls of the gut. By binding to these receptors dicycloverine prevents certain chemicals produced by the body from interacting with these receptors. This causes the gut muscle to relax, relieving the pain of colic produced by gut muscle contraction and spasm.

For oral dosage forms:

• Adults:10 to 20 mg three times a day.
• Children over 6 months of age: 5 to 10 mg three times a day.

For injectable dosage form:

• Adults: Intramuscular injection. Not for intravenous use. The recommended intramuscular dose is 80 mg daily (in 4 equally divided doses).

Oral dicycloverine Hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

Children: Dose must be determined by the doctor.

Insomnia, mydriasis, cycloplegia, increased ocular tension, urinary hesitancy, palpitations, dyspnea.

Use with caution in patients with autonomic neuropathy, hepatic or renal disease, ulcerative colitis, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia, hiatal hernia, known or suspected prostatic hypertrophy.

Pregnancy Category B. Dicycloverine was neither teratogenic nor embryocidal in animal trial. It, like other drugs should be used during pregnancy only if clearly needed. There are no data on the secretion of this drug into breast milk. Dicycloverine should be used cautiously in case of lactating mother.

Toxic reaction seldom occurs with dicycloverine. The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation.

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

Multi-vitamin & Multi-mineral combined preparations

This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.

One tablet daily or as recommended by the physician.

Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.

No drug interactions have been reported.

Recommended by the consultation with physician.

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

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

Diclofenac Sodium is a potent nonsteroidal antiinflammatory drug (NSAID) with marked analgesic and antipyretic properties. It also has some uricosuric effects. The action of Diclofenac appeared to be associated with the inhibition of prostaglandin synthesis. Diclofenac may inhibit synthesis of prostaglandins by inhibiting cyclooxygenase, an enzyme that catalyses the formation of prostaglandin precursors from arachidonic acid. Peak plasma concentration is achieved within half an hour following injection. Lidocaine is the most widely used local anaesthetic drug. It acts more rapidly and is more stable than most other local anaesthetics. It is a very useful surface anaesthetic. Like other local anaesthetics, Lidocaine impairs the generation and conduction of nerve impulses by slowing depolarization. The onset of anaesthesia of Lidocaine Hydrochloride is more rapid and the duration is 1-2 hours.

Adult: One ampoule once (or in severe cases, twice) daily by intramuscular injection.

Renal colic: One ampoule once daily intramuscularly. A second dose may be administered after 30 minutes if necessary.

Children: In Juvenile chronic arthritis, 1-3 mg of Diclofenac Sodium per kg body weight daily in divided doses.

Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status, or as prescribed by the physician.

Side effects to Diclofenac Sodium and Lidocaine injection are usually mild and transient. However if serious side effects occur the injection should be discontinued. Gastrointestinal discomfort, nausea, diarrhea and occasionally bleeding may occur. In very rare instances, injection site disorder may occur. In isolated cases, abscesses and local necrosis may occur. The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration, and are dose related. The CNS reactions may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadedness etc.

It is contraindicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity Diclofenac is also contraindicated. Because of the presence of Lidocaine, this injection is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare. In patients with Adams-Stokes syndrome or with severe degrees of SA, AV, or intraventricular heart block in the absence of an artificial pacemaker, and for those patients who are hypersensitive to any of the excipients used in the formulation (Sodium Metabisulphite, Disodium Edetate, Benzyl Alcohol, Sodium Hydroxide, Propylene Glycol), this injection is also contraindicated.

Renal: Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close observation, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function should be monitored.

Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac should be discontinued. All patients who are receiving long term treatment with NSAIDs should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).

Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.

Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy, although clinical investigations do not appear to indicate any influence on anticoagulant effect.

Antidiabetic agents: Clinical studies have shown that Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect.

Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.

Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.

Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. Therefore, caution should be exercised when considering concomitant therapy of NSAIDs and quinolones.

Other NSAIDs and steroids: Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With Aspirin, the plasma levels of each are lowered, although no clinical significance is known.

Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels. So, serum potassium should be monitored.

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

Store at temparature not exceeding 30°C in a dry place. Protected from light.

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

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Dextromethorphan is indicated in Chronic dry cough or unproductive cough; Acute dry cough which is interfering with normal function or sleep.

Cough suppressant

Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Adults and Children over 12 years: 15 to 30 mg three to four times per day. However, 60 mg doses up to four times per day have been used without increased side effects.
Children between 6 and 12 years: 5-15 mg up to four times per day.
Children between 2 and 6 years: 2.5-5 mg up to four times per day.

Adverse effects with Dextromethorphan are rare, but nausea and dizziness sometimes occur. The drug produces no analgesia or addiction and little or no CNS depression. Excitation, confusion and respiratory depression may occur after overdosage.

Hypersensitivity to Dextromethorphan or any other component.

Do not use Dextromethorphan to control a cough that is associated with smoking, asthma, or emphysema, or a cough that is productive (produces sputum or phlegm).

The following medicines should be taken carefully while concomitantly use with Dextromethorphan: Amiodarone, Fluoexetine, Quinidine, CNS depressants and Monoamine oxidase (MAO) inhibitors.

Pregnancy: Adequate and well-controlled studies in human have not been done. However, Dextromethorphan has not been reported to cause birth defects.

Lactation: It is not known whether dextromethorphan passes into breast milk. However, Dextromethorphan has not been reported to cause problems in nursing babies.

Symptoms: In mild overdose, tachycardia, hypertension, vomiting, mydriasis, diaphoresis, nystagmus, euphoria, loss of motor coordination, and giggling; in moderate intoxication, in addition to those listed above, hallucinations and a plodding ataxic gait; in severely intoxication, agitation or somnolence.

Management: treatment is symptomatic and supportive. Naloxone may be useful in reversing toxicity.

Store at 15-30° C

Temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• cough due to minor throat or bronchial irritation
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. It is used to treat nasal and sinus congestion of the tubes that drain fluid from inner ear. Triprolidine provides symptomatic relief in conditions believed to depend wholly or partly upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.

Adults & Children 12 years of age and older: 1 teaspoonful (5 ml) every 4 hours, or as directed by a doctor.

Children 6 to under 12 years of age: ½ teaspoonful (2.5 ml) every 4 hours, or as directed by a doctor.

Children below 2 years old: Not to be used in children below 2 years old. To be used with caution, and as advised by the physician for children age 2 to 6 years.

Take with or without food. Take with food if it causes an upset stomach. Measure liquid doses carefully. Use the measuring device that comes with this medicine.

It may cause drowsiness, dottiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type. Other less common side effects may include transient hypertension, dry mouth, restlessness, palpitations, allergic reactions such as rashes, tightness of chest, thickening of bronchial secretions, toxic psychosis and blood dyscrasia.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment, known hypersensitivity to phenylephrine hydrochloride, dextromethorphan hydrobromide and during acute attacks of asthma. It is contraindicated in patients with severe hypertension or severe coronary artery disease.

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism, patients with stenosing peptic ulcer, pyloro-duodenal obstruction or bladder neck obstruction, unless under the medical advice and supervision. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Caution should be excercised while taking this drug with antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), antispasmodics (e.g. atropine, belladonna alkaloids), beta blockers (e.g. metoprolol, atenolol), drugs for Parkinson’s disease (e.g. anticholinergics such as benztropine, trihexyphenidyl), guanethidine, certain inhaled anesthetics (e.g. halothane), methyldopa, reserpine, scopolamine, tricyclic antidepressants (e.g. amitriptyline, desipramine), anti seizure drugs (e.g. carbamazepine), medicine for sleep or anxiety (e.g. alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g. codeine), psychiatric medicines (e.g. chlorpromazine, risperidone, amitriptyline, trazodone).

As with any other drugs, use in pregnancy and lactation is best avoided.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations, and convulsion. Treatment should include emptying the stomach by aspiration or gastric lavage. Nervous stimulation and convulsions should be treated with a sedative such as diazepam intramuscularly. If marked excitation is present, a sedative such as diazepam or a short-acting barbiturate may be given.

Severe over dosage of phenylephrine hydrochloride may produce hypertension and associated reflex bradycardia. Treatment measures include early gastric lavage and symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-receptor blocking agent (such as phentolamine mesilate 6-10 mg) given intravenously, and the bradycardia treated with atropine, preferable only after the pressure has been controlled.

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

Nalidixic acid is indicated in the treatment of urinary tract infection caused by susceptible Gram-negative organisms, including Proteus species, Klebsiella species, Enterobacter species and Escherichia coli.

Anti-diarrhoeal Antimicrobial drugs, Other Anti-protozoals, Systemic Urinary Anti- infective

Nalidixic acid is a synthetic narrow spectrum antibacterial. It is bacteriostatic or bactericidal depending on the concentration. Nalidixic acid appears to act by inhibiting bacterial DNA synthesis, possibly by interfering with DNA polymerization. It is rapidly and completely absorbed from the G.I. Tract. Parent drug and active metabolites are distributed to most tissues specially to the kidney and to the urine. During normal renal function, half-life is 1.1 to 2.5 hours and when renal function is impaired, half-life is up to 21 hours. It is rapidly and almost completely excreted within 24 hours.

Adult: initially is 1 g every 6 hours for 7 days reducing to 500 mg every 6 hours.

Children: Infants and children 3 month of age and over Initial: Oral 13.75 mg per kg body weight every six hours for one or two weeks. Maintenance: Oral 8.25 mg per kg body weight every six hours or as prescribed by the physician.

Gastro-intestinal disturbances including nausea, vomiting, diarrhoea, haemolysis in G6PD deficiency, allergic reaction including urticaria, rashes, fever, arthralgia, eosinophilia, also myalgia, muscle weakness, phototoxicity, jaundice, visual disturbances and convulsions.

Nalidixic acid is contraindicated in the following cases- Infants under 3 months, epilepsy, CNS lesions.

Risk-benefit must be considered during the first trimester of pregnancy and during breast feeding, impaired renal or hepatic function.

Concomitant use of Nalidixic acid with melphalan there have been reports of death froms severe blood containing diarrhoea caused by hemorrhagic ulcerative colitis. Probenecids inhibits tubular secretion of nalidixic acid and may therefore elevate serum concentration, possibly enhancing toxicity. Chlorpromazine and Perphenazine have been shown to potentiate the effect of Nalidixic Acid in vitro.

There is the possibility that it may cause cartilage damage and as it is a DNA-gyrase inhibitor there is a possibility of causing DNA damage too. Nalidixic acid is excreted in breast milk and there is a report of hemolytic anaemia in a breast feed child of an azotemic mother.

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

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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

Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.

Anti-histamine Preparations, Other drugs for migraine

Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.

Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.

Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.

The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.

Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.

Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.

The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.

Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.

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

Calcium Dobesilate is indicated for the treatment of hemorrhoidal syndrome, microcirculation disorders of arteovenous origin, clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, edema, stasis, dermotosis) and in the particular microangiopathy like diabetic retinopathy. It is also indicated in superficial thrombophlebitis as adjuvant therapy.

Vaso Protective

Calcium dobesilate acts selectively on the capillary walls regulating their physiological functions of resistance and permeability. It lowers blood viscosity and restores normal blood flow. This action is beneficial in all cases of capillary fragility due to metabolic disturbances (constitutional or acquired), and surgical stress or induced by certain medicines.

Calcium Dobesilate capsule once or twice daily should be taken with the main meal. Treatment duration, which generally between a few weeks to several months, depends on the disease and its evolution. Dosage should be adapted individually according to the severity of the disease.

Rarely gastrointestinal disorders including nausea and diarrhea, skin reactions, fever, articular pain and in very rare cases agranulocytosis have been reported. These reactions are generally spontaneously reversible after treatment withdrawal.

Hypersensitivity. Pregnancy and lactation.

Dosage should be reduced in case of severe renal insufficiency requiring dialysis. In patient with agranulocytosis, this medication can decrease the number of white blood cells which affect the body’s ability to fight against various infections. If patients experience flu-like symptoms such as cough, sore throat, fever and others, they are advised to seek medical care as soon as possible.

The safety of Calcium Dobesilate during pregnancy and lactation has not been established. As it is not known whether calcium dobesilate crosses the placental barrier in humans, the drug should be administered during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus. Avoid breastfeeding while using this medicine.

The clinical signs of a possible overdose are not known. If overdose occurs, seek medical advice immediately.

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

Calcium Dobesilate is indicated for the treatment of hemorrhoidal syndrome, microcirculation disorders of arteovenous origin, clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, edema, stasis, dermotosis) and in the particular microangiopathy like diabetic retinopathy. It is also indicated in superficial thrombophlebitis as adjuvant therapy.

Vaso Protective

Calcium dobesilate acts selectively on the capillary walls regulating their physiological functions of resistance and permeability. It lowers blood viscosity and restores normal blood flow. This action is beneficial in all cases of capillary fragility due to metabolic disturbances (constitutional or acquired), and surgical stress or induced by certain medicines.

Calcium Dobesilate capsule once or twice daily should be taken with the main meal. Treatment duration, which generally between a few weeks to several months, depends on the disease and its evolution. Dosage should be adapted individually according to the severity of the disease.

Rarely gastrointestinal disorders including nausea and diarrhea, skin reactions, fever, articular pain and in very rare cases agranulocytosis have been reported. These reactions are generally spontaneously reversible after treatment withdrawal.

Hypersensitivity. Pregnancy and lactation.

Dosage should be reduced in case of severe renal insufficiency requiring dialysis. In patient with agranulocytosis, this medication can decrease the number of white blood cells which affect the body’s ability to fight against various infections. If patients experience flu-like symptoms such as cough, sore throat, fever and others, they are advised to seek medical care as soon as possible.

The safety of Calcium Dobesilate during pregnancy and lactation has not been established. As it is not known whether calcium dobesilate crosses the placental barrier in humans, the drug should be administered during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus. Avoid breastfeeding while using this medicine.

The clinical signs of a possible overdose are not known. If overdose occurs, seek medical advice immediately.

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

This rectal ointment is indicated in-

• Internal and external hemorrhoids,
• Anal pruritus
• Anal eczema
• Anitis
• Perianitis
• Acute hemorrhoidal thrombosis 
• Anal fissure
• Pre and postoperative treatment in cases of hemorrhoidectomy

A long-lasting treatment is not indicated.

Drugs used in Ano-rectal region

Calcium Dobesilate acts on the capillary walls by regulating their impaired physiological functions- i.e. increased permeability and decreased resistance and on different signs of inflammation. It also has an antithrombotic activity. Lidocaine hydrochloride, a local anesthetic, contributes to relieve pain. Dexamethasone Acetate, a Corticosteroid for topical use, possesses anti-inflammatory and antipruritic actions.

2-3 times daily. Apply in the morning and bedtime and if possible after defecation. If the ointment is preferred, use the applicator by screwing it to the tube. Insert the applicator as deep as possible in the anus then press the tube gently while withdrawing it. In this case, the tube is sufficient for 8 applications. In case of external hemorrhoids or anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The doctor must be informed if, after 1 to 2 weeks of treatment, the symptomatology has not improved or has worsened.

Calcium Dobesilate, Lidocaine HCI & Dexamethasone Acetate Ointment should be applied 2-3 times daily preferably in the morning and at bedtime, if possible apply after defecation. In the case of internal hemorrhoids apply the ointment by the applicator. In cases of external hemorrhoids and anal pruritus, apply a thin layer of the ointment several times a day. The duration of the treatment is generally of some days. The physician must be informed if, after 1 to 2 weeks of treatment the symptomatology has not improved or has worsened.

Method of use of this ointment:
For internal use-

• Before use remove the cap from the tube.
• Pierce the tube membrane by inverting the cap.
• Attach the applicator (supplied) to the tube.
• Squeeze the tube to fill the applicator and lubricate the tip with ointment for smooth insertion.
• Insert the applicator gently and to full extend into the anus and squeeze once again from the end of the tube to force the required amount of ointment into the anal canal.
• Remove the applicator after application and discard it.
• Try not to have defecation for a couple of hours after an internal application.

For external use-

• Squeeze the tube of ointment and apply a small amount to the finger.
• Apply the ointment around the outside of the anus with a finger.
• Wash the hands thoroughly with warm water and soap after each application.
• Reattach the cap to tube.

Very rare cases have been reported: Modifications of the intestinal transit, temporary burning sensation and local pain. Hypersensitivity reactions together with skin reactions and/or fever can occur. These reactions can be of allergic origin and in this case, the treatment must be discontinued.

Hypersensitivity towards the components of this preparation.

In case of renal insufficiency, this rectal ointment should not be used during longer periods. Avoid long-lasting treatments.

Pregnancy category C. Studies in pregnant women or animals are not available and in humans, it is not known whether Calcium Dobesilate crosses the placental barrier. On the other hand, after topical administration, Lidocaine Hydrochloride and Dexamethasone Acetate are resorbed in variable quantities and can have systemic effects. Moreover, both substances cross the placental barrier. In these conditions, this rectal ointment should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. After oral administration, Calcium Dobesilate is excreted in the maternal milk in low amounts but it is not known whether this is the case with local use. After topical administration, Lidocaine Hydrochloride and Dexamethasone Acetate are excreted in the maternal milk. As a precaution, it should be decided between discontinuating the treatment or the breast-feeding.

No overdosage information found yet.

The ointment must be stored protected from heat. Store it below 30°C.

Calcium Dobesilate is indicated for the treatment of hemorrhoidal syndrome, microcirculation disorders of arteovenous origin, clinical signs of chronic venous insufficiency in the lower limbs (pain, cramps, paresthesia, edema, stasis, dermotosis) and in the particular microangiopathy like diabetic retinopathy. It is also indicated in superficial thrombophlebitis as adjuvant therapy.

Vaso Protective

Calcium dobesilate acts selectively on the capillary walls regulating their physiological functions of resistance and permeability. It lowers blood viscosity and restores normal blood flow. This action is beneficial in all cases of capillary fragility due to metabolic disturbances (constitutional or acquired), and surgical stress or induced by certain medicines.

Calcium Dobesilate capsule once or twice daily should be taken with the main meal. Treatment duration, which generally between a few weeks to several months, depends on the disease and its evolution. Dosage should be adapted individually according to the severity of the disease.

Rarely gastrointestinal disorders including nausea and diarrhea, skin reactions, fever, articular pain and in very rare cases agranulocytosis have been reported. These reactions are generally spontaneously reversible after treatment withdrawal.

Hypersensitivity. Pregnancy and lactation.

Dosage should be reduced in case of severe renal insufficiency requiring dialysis. In patient with agranulocytosis, this medication can decrease the number of white blood cells which affect the body’s ability to fight against various infections. If patients experience flu-like symptoms such as cough, sore throat, fever and others, they are advised to seek medical care as soon as possible.

The safety of Calcium Dobesilate during pregnancy and lactation has not been established. As it is not known whether calcium dobesilate crosses the placental barrier in humans, the drug should be administered during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus. Avoid breastfeeding while using this medicine.

The clinical signs of a possible overdose are not known. If overdose occurs, seek medical advice immediately.

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

Cytotoxic Chemotherapy

Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.

Administer Doxorubicin at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution.

• Ovarian cancer: 50 mg/m2 IV every 4 weeks
• AIDS-related Kaposi’s Sarcoma: 20 mg/m2 IV every 3 weeks
• Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib

Leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea. Rarely facial flushing, rash, alopecia. Blurred vision, headache, seizures, paraesthesia, confusion, malaise, lethargy, skin pigmentation.

Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy.

Elderly, children, hepatic impairment. Monitor blood counts and ECG.

Doxorubicin interacts with a number of other drugs e.g. antibiotics (aminoglycosides), steroids, aminophylline and propranolol.

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).

Hepatic Impairment-
 
serum-bilirubin: 12-30 mcg/ml: Half the normal dose;
serum-bilirubin: >30 mcg/ml: Quarter of the usual dose.

Acute overdosage may increase the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment includes hospitalisation of the severely myelosuppressed patient, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of haemopoietic growth factor (G-CSF, GM-CSF) may be considered. Cumulative dosage increases risk of cardiomyopathy and resultant congestive heart failure which may be managed with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.

Powder for injection: Store at 15-30°C.
Solution for injection & liposomal formulations: Refrigerate at 2-8°C. Do not freeze.

Inotropic-sympathomimetics

Dobutamine exerts positive inotropic effect on the myocardium by stimulating β1-adrenergic receptors, thereby increasing myocardial contractility, stroke vol and cardiac output.

Recommended Dosage: The rate of infusion needed to increase cardiac output has ranged from 2.5 to 10 mcg/kg/min in the majority of patients. Frequently, doses up to 20 mcg/kg/min are required for adequate haemodynamic improvement. On rare occasions, infusion rates up to 40 mcg/kg/min have been reported.

The rate of administration and the duration of therapy should be adjusted according to the patient's response, The indicators are: haemodynamic parameters such as heart rate and rhythm, arterial pressure, and, whenever possible, cardiac output and measurements of ventricular filling pressures and signs of pulmonary congestion. Concentrations up to 5,000 mg/L have been administered to humans. The final volume administered should be determined by the fluid requirements of the patient. Rather than abruptly discontinuing therapy with Dobutamine Hydrochloride, it is often advisable to decrease the dosage gradually.

Rates of Infusion Based on Concentration of Dobutamine Hydrochloride. The rates of fluid infusion that are required to deliver specific dosages are a function of the concentration of Dobutamine Hydrochloride in the infusate. The following table provides a guideline of infusion rates (mL/kg/min) required for 3 frequently used concentrations of Dobutamine Hydrochloride (250, 500, and 1000 mg/L).

Because of its short half-life, Dobutamine Hydrochloride must be administered as a continuous intravenous infusion. Following the initiation of a constant rate infusion, or upon changing the rate, a steady-state dobutamine plasma concentration is achieved within approximately 10 minutes. Thus, loading doses or bolus injections are not necessary and are not recommended.

Increased Heart Rate, Blood Pressure, And Ventricular Ectopic Activity: A 10- to 20-mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of patients have had increased premature ventricular beats during infusions. These effects are dose related.

Hypotension: Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate.

Reactions At Sites Of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported.

Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported.

Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.

Longer-Term Safety: Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.

Dobutamine Hydrochloride is contraindicated in patients who have shown previous manifestations of hypersensitivity to Dobutamine Hydrochloride.

During the administration of Dobutamine Hydrochloride, as with any parenteral catecholamine, heart rate and rhythm, arterial blood pressure, and infusion rate should be monitored closely. When initiating therapy, electrocardiographic monitoring is advisable until a stable response is achieved.

The potency of Dobutamine Hydrochloride may be decreased if the patient is given b-adrenergic receptor antagonists. In such a case, the unopposed a-agonist effects of Dobutamine Hydrochloride may become apparent, including peripheral vasoconstriction and hypertension. Conversely, a-adrenergic blockade may make the b-1 and b-2 effects apparent, resulting in tachycardia and vasodilatation.

There has been no overt indication of medicine interactions in clinical studies in which Dobutamine Hydrochloride was administered concurrently with other medicines, including digitalis preparations, furosemide, spironolactone, lidocaine, nitroglycerin, nitroprusside, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and paracetamol.

Since there are no adequate and well controlled studies in pregnant women, Dobutamine Hydrochloride should not be used during pregnancy unless the potential benefits outweigh the potential risks to the foetus.

It is not known whether this medicine is excreted in human milk. Because many medicines are excreted in human milk, caution should be exercised when Dobutamine Hydrochloride is administered to a nursing woman. If a mother requires dobutamine treatment, breastfeeding should be discontinued for the duration of the treatment.

Signs And Symptoms: Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β- receptor stimulation. The duration of action of dobutamine hydrochloride is generally short (T½= 2 minutes) because it is rapidly metabolized by catechol-0-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropicand chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation.

Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

The initial actions to be taken in a dobutamine hydrochloride overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy.

Protect the patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emisis of lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.

Store between 15-30° C.

Inotropic-sympathomimetics

Dobutamine exerts positive inotropic effect on the myocardium by stimulating β1-adrenergic receptors, thereby increasing myocardial contractility, stroke vol and cardiac output.

Recommended Dosage: The rate of infusion needed to increase cardiac output has ranged from 2.5 to 10 mcg/kg/min in the majority of patients. Frequently, doses up to 20 mcg/kg/min are required for adequate haemodynamic improvement. On rare occasions, infusion rates up to 40 mcg/kg/min have been reported.

The rate of administration and the duration of therapy should be adjusted according to the patient's response, The indicators are: haemodynamic parameters such as heart rate and rhythm, arterial pressure, and, whenever possible, cardiac output and measurements of ventricular filling pressures and signs of pulmonary congestion. Concentrations up to 5,000 mg/L have been administered to humans. The final volume administered should be determined by the fluid requirements of the patient. Rather than abruptly discontinuing therapy with Dobutamine Hydrochloride, it is often advisable to decrease the dosage gradually.

Rates of Infusion Based on Concentration of Dobutamine Hydrochloride. The rates of fluid infusion that are required to deliver specific dosages are a function of the concentration of Dobutamine Hydrochloride in the infusate. The following table provides a guideline of infusion rates (mL/kg/min) required for 3 frequently used concentrations of Dobutamine Hydrochloride (250, 500, and 1000 mg/L).

Because of its short half-life, Dobutamine Hydrochloride must be administered as a continuous intravenous infusion. Following the initiation of a constant rate infusion, or upon changing the rate, a steady-state dobutamine plasma concentration is achieved within approximately 10 minutes. Thus, loading doses or bolus injections are not necessary and are not recommended.

Increased Heart Rate, Blood Pressure, And Ventricular Ectopic Activity: A 10- to 20-mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of patients have had increased premature ventricular beats during infusions. These effects are dose related.

Hypotension: Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate.

Reactions At Sites Of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported.

Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported.

Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.

Longer-Term Safety: Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.

Dobutamine Hydrochloride is contraindicated in patients who have shown previous manifestations of hypersensitivity to Dobutamine Hydrochloride.

During the administration of Dobutamine Hydrochloride, as with any parenteral catecholamine, heart rate and rhythm, arterial blood pressure, and infusion rate should be monitored closely. When initiating therapy, electrocardiographic monitoring is advisable until a stable response is achieved.

The potency of Dobutamine Hydrochloride may be decreased if the patient is given b-adrenergic receptor antagonists. In such a case, the unopposed a-agonist effects of Dobutamine Hydrochloride may become apparent, including peripheral vasoconstriction and hypertension. Conversely, a-adrenergic blockade may make the b-1 and b-2 effects apparent, resulting in tachycardia and vasodilatation.

There has been no overt indication of medicine interactions in clinical studies in which Dobutamine Hydrochloride was administered concurrently with other medicines, including digitalis preparations, furosemide, spironolactone, lidocaine, nitroglycerin, nitroprusside, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and paracetamol.

Since there are no adequate and well controlled studies in pregnant women, Dobutamine Hydrochloride should not be used during pregnancy unless the potential benefits outweigh the potential risks to the foetus.

It is not known whether this medicine is excreted in human milk. Because many medicines are excreted in human milk, caution should be exercised when Dobutamine Hydrochloride is administered to a nursing woman. If a mother requires dobutamine treatment, breastfeeding should be discontinued for the duration of the treatment.

Signs And Symptoms: Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β- receptor stimulation. The duration of action of dobutamine hydrochloride is generally short (T½= 2 minutes) because it is rapidly metabolized by catechol-0-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropicand chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation.

Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

The initial actions to be taken in a dobutamine hydrochloride overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy.

Protect the patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emisis of lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.

Store between 15-30° C.

Inotropic-sympathomimetics

Dobutamine exerts positive inotropic effect on the myocardium by stimulating β1-adrenergic receptors, thereby increasing myocardial contractility, stroke vol and cardiac output.

Recommended Dosage: The rate of infusion needed to increase cardiac output has ranged from 2.5 to 10 mcg/kg/min in the majority of patients. Frequently, doses up to 20 mcg/kg/min are required for adequate haemodynamic improvement. On rare occasions, infusion rates up to 40 mcg/kg/min have been reported.

The rate of administration and the duration of therapy should be adjusted according to the patient's response, The indicators are: haemodynamic parameters such as heart rate and rhythm, arterial pressure, and, whenever possible, cardiac output and measurements of ventricular filling pressures and signs of pulmonary congestion. Concentrations up to 5,000 mg/L have been administered to humans. The final volume administered should be determined by the fluid requirements of the patient. Rather than abruptly discontinuing therapy with Dobutamine Hydrochloride, it is often advisable to decrease the dosage gradually.

Rates of Infusion Based on Concentration of Dobutamine Hydrochloride. The rates of fluid infusion that are required to deliver specific dosages are a function of the concentration of Dobutamine Hydrochloride in the infusate. The following table provides a guideline of infusion rates (mL/kg/min) required for 3 frequently used concentrations of Dobutamine Hydrochloride (250, 500, and 1000 mg/L).

Because of its short half-life, Dobutamine Hydrochloride must be administered as a continuous intravenous infusion. Following the initiation of a constant rate infusion, or upon changing the rate, a steady-state dobutamine plasma concentration is achieved within approximately 10 minutes. Thus, loading doses or bolus injections are not necessary and are not recommended.

Increased Heart Rate, Blood Pressure, And Ventricular Ectopic Activity: A 10- to 20-mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of patients have had increased premature ventricular beats during infusions. These effects are dose related.

Hypotension: Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate.

Reactions At Sites Of Intravenous Infusion: Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported.

Miscellaneous Uncommon Effects: The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported.

Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels.

Longer-Term Safety: Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.

Dobutamine Hydrochloride is contraindicated in patients who have shown previous manifestations of hypersensitivity to Dobutamine Hydrochloride.

During the administration of Dobutamine Hydrochloride, as with any parenteral catecholamine, heart rate and rhythm, arterial blood pressure, and infusion rate should be monitored closely. When initiating therapy, electrocardiographic monitoring is advisable until a stable response is achieved.

The potency of Dobutamine Hydrochloride may be decreased if the patient is given b-adrenergic receptor antagonists. In such a case, the unopposed a-agonist effects of Dobutamine Hydrochloride may become apparent, including peripheral vasoconstriction and hypertension. Conversely, a-adrenergic blockade may make the b-1 and b-2 effects apparent, resulting in tachycardia and vasodilatation.

There has been no overt indication of medicine interactions in clinical studies in which Dobutamine Hydrochloride was administered concurrently with other medicines, including digitalis preparations, furosemide, spironolactone, lidocaine, nitroglycerin, nitroprusside, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and paracetamol.

Since there are no adequate and well controlled studies in pregnant women, Dobutamine Hydrochloride should not be used during pregnancy unless the potential benefits outweigh the potential risks to the foetus.

It is not known whether this medicine is excreted in human milk. Because many medicines are excreted in human milk, caution should be exercised when Dobutamine Hydrochloride is administered to a nursing woman. If a mother requires dobutamine treatment, breastfeeding should be discontinued for the duration of the treatment.

Signs And Symptoms: Toxicity from dobutamine hydrochloride is usually due to excessive cardiac β- receptor stimulation. The duration of action of dobutamine hydrochloride is generally short (T½= 2 minutes) because it is rapidly metabolized by catechol-0-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropicand chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation.

Treatment: To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

The initial actions to be taken in a dobutamine hydrochloride overdose are discontinuing administration, establishing an airway, and ensuring oxygenation and ventilation. Resuscitative measures should be initiated promptly. Severe ventricular tachyarrhythmias may be successfully treated with propranolol or lidocaine. Hypertension usually responds to a reduction in dose or discontinuation of therapy.

Protect the patient's airway and support ventilation and perfusion. If needed, meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emisis of lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of dobutamine hydrochloride.

Store between 15-30° C.

Cytotoxic Chemotherapy

Docetaxel is an antineoplastic agent, which acts by disrupting the microtubular network in cells that is essential for vital mitotic and interphase cellular functions. Docetaxel promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Docetaxel binds to free tubulin thereby decreasing the critical intracellular concentration of tubulin. The promoted polymerization of microtubules leads to the production of microtubule bundles without normal function and to the stabilization of microtubules, resulting in the inhibition of mitosis in cells. The binding of Docetaxel to microtubules does not alter the number of protofilaments in the bound microtubules; in that, it differs from other spindle poisons. Docetaxel was found to be cytotoxic in vitro against various murine and human tumor cell lines, and against freshly excised human tumor cells in clonogenic assays. In addition, Docetaxel was found to be active on a number of cell lines overexpressing the p-glycoprotein, which is encoded by the multidrug resistant gene.

Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel from the vial.

• BC locally advanced or metastatic: 60 mg/m² to 100 mg/m² single agent
• BC adjuvant: 75 mg/m² administered 1 hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles
• NSCLC: after platinum therapy failure: 75 mg/m² single agent
• NSCLC: chemotherapy-naive: 75 mg/m² followed by cisplatin 75 mg/m² 
• HRPC: 75 mg/m2 with 5 mg prednisone twice a day continuously
• GC: 75 mg/m² followed by cisplatin 75 mg/m² (both on day 1 only) followed by fluorouracil 750 mg/m² per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion
• SCCHN: 75 mg/m² followed by cisplatin 75 mg/m² IV (day 1), followed by fluorouracil 750 mg/m² per day as a 24-hr IV (days 1–5), starting at end of cisplatinin fusion; for 4 cycles
• SCCHN: 75 mg/m² followed by cisplatin 100 mg/m² IV (day 1), followed by fluorouracil 1000 mg/m² per day as a 24-hr IV (days 1–4); for 3 cycles

For all patients:

• Premedicate with oral corticosteroids
• Adjust dose as needed

The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Docetaxel is contraindicated in patients with:

• Neutrophil counts of <1500 cells/mm³
• A history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe reactions, including anaphylaxis, have occurred

Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce, inhibit, or are metabolized by cytochrome P450 3A4.

Based on findings in animal reproduction studies and its mechanism of action, docetaxel can cause fetal harm when administered to a pregnant woman. There is no information regarding the presence of docetaxel in human milk, or on its effects on milk production or the breastfed child. No lactation studies in animals have been conducted.

There were a few reports of overdosage. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In case of overdosage, exacerbation of adverse events may be expected. The primary anticipated complications of overdosage would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.

Store between 2°C and 25°C and protected from light. Freezing does not adversely affect the product.