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SKINALAR Cream and Ointment : White, water miscible cream and greasy ointment containing Fluocinolone Acetonide BP 0.025% w/w.
SKINALAR-N Cream and Ointment: White, 'Water miscible cream and greasy ointment containing Fluocinolone Acetonide BP 0.025% w/w and Neomycin Sulphate BP 0.5% wlw.
Uses
SKINALAR Cream and Ointment are suitable for treating a wide variety of local inflammatory, pruritic and allergic disorders of the skin.
SKINALAR is particularly suitable for topical application in :
Eczema and dermatitis : atopic eczema, seborrhoeic eczema, discoid eczema, otitis externa, contact dermatitis, neurodermatitis.
Prurigo, Psoriasis, lichen planus. Discoid lupus erythematosus.
SKINALAR-N is indicated for inflammatory dermatoses, where secondary bacterial infection is present or likely to occur.
Dosage and administration
A small quantity of SKINALAR or SKINALAR-N is applied lightly up to two or three times a day, and massaged gently and thoroughly into the skin. These recommendations apply to
both children and adults, including the elderly.
Contra-Indications, warnings, etc.
Contra-indications : SKINALAR - Primary infections of the skin and in rosacea, acne, perioral dermatitis, anogenital pruritus and napkin eruption.
SKINALAR-N - As for SKINALAR. Also known hypersensitivity to neomycin.
Precautions : SKINALAR - Appropriate anti-infective cover should be given if there is an associated infection.
SKINALAR-N - Appropriate anti-Infective cover should be given in the presence of viral or fungal infection. Prolonged use should be avoided in conditions where absorption of neomycin is possible. Do not apply to the external auditory canal of patiente with perforated eardrums.
SKINALAR and SKINALAR-N : Long-term continuous topical steroid therapy can produce atrophic skin changes. Do not apply to the face for prolonged periods. Prolonged use or treatment of extensive areas can produce adrenal suppression,especially in infants and children.
Pregnancy : Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intrauterine growth retardation. There may be a very small risk of such effects on the human foetus.
Lactation : When topical steroid treatment is necessary, minimise amount and length of treatment.
Side-effects: With SKINALAR, side-effects are extremely rare, but as with all topical corticosteroids, patient may show hypersensitivity reaction.
Pharmaceutical precautions
Store at temperature below 30·C.
Package quantities
SKINALAR Cream and Ointment : 5g/15g . Tube.
SKINALAR-N Cream and Ointment :5g/15g Tube.
To be dispensed only by or on the prescription of a registered physician
Saturday, November 15, 2008
Prosma
Prosma
Prosma® Tablets: White, diamond shaped, scored tablets having P at one side and A on another side of breakline; each
tablet contains Kelotifen fumarate BP equivalent to 1mg Ketotifen.
Prosma® Syrup: Yellow coloured, lemon flavoured syrup; each 5ml contains Ketotifen fumarate BP equivalent to 1 mg Ketotifen.
Uses
Prosma® is a non-bronchodilator anti-asthmatic drug with marked anti-anaphylactic and special antihistaminic properties. In addition, Prosma® exerts a powerful and sustained H1-receptor blocking activity which can be clearly dissociated from its anti-anaphylactic properties.
It is indicated in long-term prevention of
- Bronchial asthma (all forms including mixed)
- Allergic bronchitis
- Asthmatic symptoms associated with hay fever Prevention and treatment of
- Multi-system allergies
- Allergic rhinitis
- Skin and food allergy
Dosage and administration
Adults: 1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily in severe cases. Initial treatment in readily sedated patients is 0.5mg (1/2 tablet) twice
daily or 1mg at night.
Children over 2 years of age may be given 1 mg twice daily with meal. Children aged 6 months to 2 years 0.5mg (1/2 tablet or 2.5ml syrup) twice daily.
Contra-indications, warnings, etc.
Contra-indications:A reversible fall in the platelet count has been observed in few patients receiving Ketotifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Use in pregnancy and lactation: It should not be used in pregnancy and during breast feeding, although there is no evidence of teratogenic effect.
Precaution: Previous anti-asthmatic treatment should be continued for a minimum of 2 weeks after initiation of Ketotifen treatment. Exacerbation of asthma may occur related to stopping existing treatment. This. applies especially to systemic corticosteroid and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patients. In such cases recovery of a normal pituitary adrenal response to stress may take upto one year. If intercurrent infection occurs the treatment must supplemented with specific antimicrobial therapy.
Side-effects: Drowsiness and in isolated cases dry mouth and slight dizziness may occur at the beginning of the treatment, but usually disappear spontaneously after a few days.
Pharmaceutical precautions
Store in a cool place (below 30°C), protected from light and moisture.
Package quantities
Prosma® Tablet: Cartons of 100 tablets in strips.
Prosma® Syrup: Bottles of 100ml.
ACI Limited
Prosma® Tablets: White, diamond shaped, scored tablets having P at one side and A on another side of breakline; each
tablet contains Kelotifen fumarate BP equivalent to 1mg Ketotifen.
Prosma® Syrup: Yellow coloured, lemon flavoured syrup; each 5ml contains Ketotifen fumarate BP equivalent to 1 mg Ketotifen.
Uses
Prosma® is a non-bronchodilator anti-asthmatic drug with marked anti-anaphylactic and special antihistaminic properties. In addition, Prosma® exerts a powerful and sustained H1-receptor blocking activity which can be clearly dissociated from its anti-anaphylactic properties.
It is indicated in long-term prevention of
- Bronchial asthma (all forms including mixed)
- Allergic bronchitis
- Asthmatic symptoms associated with hay fever Prevention and treatment of
- Multi-system allergies
- Allergic rhinitis
- Skin and food allergy
Dosage and administration
Adults: 1mg twice daily with food. If necessary the dose may be increased to 2mg twice daily in severe cases. Initial treatment in readily sedated patients is 0.5mg (1/2 tablet) twice
daily or 1mg at night.
Children over 2 years of age may be given 1 mg twice daily with meal. Children aged 6 months to 2 years 0.5mg (1/2 tablet or 2.5ml syrup) twice daily.
Contra-indications, warnings, etc.
Contra-indications:A reversible fall in the platelet count has been observed in few patients receiving Ketotifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided.
Use in pregnancy and lactation: It should not be used in pregnancy and during breast feeding, although there is no evidence of teratogenic effect.
Precaution: Previous anti-asthmatic treatment should be continued for a minimum of 2 weeks after initiation of Ketotifen treatment. Exacerbation of asthma may occur related to stopping existing treatment. This. applies especially to systemic corticosteroid and ACTH because of the possible existence of adrenocortical insufficiency in steroid dependent patients. In such cases recovery of a normal pituitary adrenal response to stress may take upto one year. If intercurrent infection occurs the treatment must supplemented with specific antimicrobial therapy.
Side-effects: Drowsiness and in isolated cases dry mouth and slight dizziness may occur at the beginning of the treatment, but usually disappear spontaneously after a few days.
Pharmaceutical precautions
Store in a cool place (below 30°C), protected from light and moisture.
Package quantities
Prosma® Tablet: Cartons of 100 tablets in strips.
Prosma® Syrup: Bottles of 100ml.
ACI Limited
Nugesic
Nugesic Tablet: Each tablet contains Thiamine Mononitrate (Vitamin B1) BP 100 mg, Pyridoxine Hydrochloride (Vitamin B6) BP 200 mg, Cyanocobalamin (Vitamin B12) BP
200 mcg. .
Phannacology:
Nugesic is a combination of neutropic vitamins eg Thiamine Mononitrate (Vitamin B1),Pyridoxine Hydrochloride (Vitamin B6), Cyanocobalamin (Vitamin B12).These vitamins, for their role as co-enzyme are indispensable factors in the metabolism of the nervous system. Nugesic normalizes the nerve cell metabolism. Nugesic supports the regeneration of nerve fibers and myelin sheath by activation of the metabolism and the natural repair mechanism. The analgesic effect of Nugesic is attributed to an increased availability and/or effectiveness of noradrenaline and 5-hydroxytryptamine acting as inhibitory transmitters in the nociceptive system. High doses of these vitamins administered alone or in combination inhibited nociceptive behavior and depressed the nociceptive activity evoked in single neuron of the dorsal horn of the spinal cord and in the thalamus. Moreover, they were found to enhance the antinociceptive effect of non-opjoid analgesic agents. .
Indication:
Nugesic is indicated for the treatment of following diseases:
Neuropathy, Neuritis, Neuralgia, Cervical Syndrome, Shoulder Arm Syndrome, Lumbago, Sciatica, Myalgia, Intercostal Neuralgia, Trigeminal Neuralgia and Arthritis.
It is also indicated where a deficiency of the relevant vitamins exists.
Dosage and Direction for Use:
Nugesic is tablet may be administered in a dose of 1 to 3 tablets daily or as directed by the physician.
Side Effect:
Nugesic is generally well tolerated. In rare cases few allergic responses may be seen.
Precaution:
Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin is not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of Cyanocobalamin.
Contraindication:
Nugesic should not be used in patients on Levodopa therapy or hypersensitivity to any of the active ingredients.
Use in Pregnancy & lactation:
Sufficient data yet not available in this respect.
Drug Interaction:
No drug interactions have yet been reported.
Storage Instruction:
Store in a cool and dry place, protected from light & moisture.
Commercial Pack:
Each commercial pack contains 30 tablets in Alu-PVDC blister pack.
Manufactured by :
Orion Laboratories Limited
200 mcg. .
Phannacology:
Nugesic is a combination of neutropic vitamins eg Thiamine Mononitrate (Vitamin B1),Pyridoxine Hydrochloride (Vitamin B6), Cyanocobalamin (Vitamin B12).These vitamins, for their role as co-enzyme are indispensable factors in the metabolism of the nervous system. Nugesic normalizes the nerve cell metabolism. Nugesic supports the regeneration of nerve fibers and myelin sheath by activation of the metabolism and the natural repair mechanism. The analgesic effect of Nugesic is attributed to an increased availability and/or effectiveness of noradrenaline and 5-hydroxytryptamine acting as inhibitory transmitters in the nociceptive system. High doses of these vitamins administered alone or in combination inhibited nociceptive behavior and depressed the nociceptive activity evoked in single neuron of the dorsal horn of the spinal cord and in the thalamus. Moreover, they were found to enhance the antinociceptive effect of non-opjoid analgesic agents. .
Indication:
Nugesic is indicated for the treatment of following diseases:
Neuropathy, Neuritis, Neuralgia, Cervical Syndrome, Shoulder Arm Syndrome, Lumbago, Sciatica, Myalgia, Intercostal Neuralgia, Trigeminal Neuralgia and Arthritis.
It is also indicated where a deficiency of the relevant vitamins exists.
Dosage and Direction for Use:
Nugesic is tablet may be administered in a dose of 1 to 3 tablets daily or as directed by the physician.
Side Effect:
Nugesic is generally well tolerated. In rare cases few allergic responses may be seen.
Precaution:
Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin is not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of Cyanocobalamin.
Contraindication:
Nugesic should not be used in patients on Levodopa therapy or hypersensitivity to any of the active ingredients.
Use in Pregnancy & lactation:
Sufficient data yet not available in this respect.
Drug Interaction:
No drug interactions have yet been reported.
Storage Instruction:
Store in a cool and dry place, protected from light & moisture.
Commercial Pack:
Each commercial pack contains 30 tablets in Alu-PVDC blister pack.
Manufactured by :
Orion Laboratories Limited
Noak Aceclofenac
Noak (Aceclofenac) is a phenylacetic acid derivative and related to diclofenac, developed with the aim of producing a NSAID with an improved safety profile.
Composition
Each tablet contains Aceclofenac BP 100 mg.
Mode of Action
Noak (Aceclofenac) acts primarily by inhibiting prostaglandin synthesis. Aceclofenac is a potent inhibitor of cyclooxygenase, which is involved in the production of prostaglandin.
Pharmacokinetics
Noak (Aceclofenac) is well absorbed from the gastrointestinal tract; peak plasma concentration is reached 1-3 hours after an oral dose. Plasma elimination half-life is about 4 hours.
Indications
Noak (Aceclofenac) is indicated for the symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and primary dysmenorrhoea.
Dosage and Administration
The maximum recommended dose is 200 mg daily in two divided doses. Reduction of dose is not necessary in case of elderly.
In renal failure: Dose adjustment is not necessary in mild renal insufficiency.
In hepatic failure: Dose should be decreased in patients with easy to moderately severe liver malfunction. The recommended initial daily dose is 100 mg in that case.
Side Effects
The major side effects are gastrointestinal like dyspepsia, abdominal pain, nausea, and diarrhea. Flatulence, gastritis, constipation, vomiting etc may also occur.
Contraindications
Noak (Aceclofenac) is contraindicated in the following situations:
* Patients previously sensitive to Aceclofenac or Aspirin or other NSAIDs
* Patients with active or suspected peptic or duodenal ulcer or who have GI or other bleeding disorders.
* In severe heart failure and renal or hepatic insufficiency.
* During last three months of pregnancy.
Precautions
Noak (Aceclofenac) should be used with caution in patients suffering from GI disease and history of peptic ulceration, cerebrovascular bleeding, ulcerative colitis or coagulation disorders.
Caution should be exercised in patients with mild to moderate renal, hepatic or cardiac function. Caution is also required in patients with diuretic treatment.
Drug Interactions
Noak (Aceclofenac) is metabolized through cytochrome P4502C9 and a risk of pharmacokinetic interaction is, therefore, possible with Phenytoin, Digoxin, Cimetidine, Tolbutamide. There is also a risk of pharmacokinetic interactions with drugs eliminated by active renal secretion such as Methotrexate and Lithium.
Use in Pregnancy and Lactation
There is no information on the use of Aceclofenac during pregnancy and lactation. The use of Noak (Aceclofenac) should, therefore, be avoided during pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks.
Storage
Store in a cool and dry place, away from light.
Commercial Pack
Box containing 5 x 10 Tablets in blister pack.
Composition
Each tablet contains Aceclofenac BP 100 mg.
Mode of Action
Noak (Aceclofenac) acts primarily by inhibiting prostaglandin synthesis. Aceclofenac is a potent inhibitor of cyclooxygenase, which is involved in the production of prostaglandin.
Pharmacokinetics
Noak (Aceclofenac) is well absorbed from the gastrointestinal tract; peak plasma concentration is reached 1-3 hours after an oral dose. Plasma elimination half-life is about 4 hours.
Indications
Noak (Aceclofenac) is indicated for the symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and primary dysmenorrhoea.
Dosage and Administration
The maximum recommended dose is 200 mg daily in two divided doses. Reduction of dose is not necessary in case of elderly.
In renal failure: Dose adjustment is not necessary in mild renal insufficiency.
In hepatic failure: Dose should be decreased in patients with easy to moderately severe liver malfunction. The recommended initial daily dose is 100 mg in that case.
Side Effects
The major side effects are gastrointestinal like dyspepsia, abdominal pain, nausea, and diarrhea. Flatulence, gastritis, constipation, vomiting etc may also occur.
Contraindications
Noak (Aceclofenac) is contraindicated in the following situations:
* Patients previously sensitive to Aceclofenac or Aspirin or other NSAIDs
* Patients with active or suspected peptic or duodenal ulcer or who have GI or other bleeding disorders.
* In severe heart failure and renal or hepatic insufficiency.
* During last three months of pregnancy.
Precautions
Noak (Aceclofenac) should be used with caution in patients suffering from GI disease and history of peptic ulceration, cerebrovascular bleeding, ulcerative colitis or coagulation disorders.
Caution should be exercised in patients with mild to moderate renal, hepatic or cardiac function. Caution is also required in patients with diuretic treatment.
Drug Interactions
Noak (Aceclofenac) is metabolized through cytochrome P4502C9 and a risk of pharmacokinetic interaction is, therefore, possible with Phenytoin, Digoxin, Cimetidine, Tolbutamide. There is also a risk of pharmacokinetic interactions with drugs eliminated by active renal secretion such as Methotrexate and Lithium.
Use in Pregnancy and Lactation
There is no information on the use of Aceclofenac during pregnancy and lactation. The use of Noak (Aceclofenac) should, therefore, be avoided during pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks.
Storage
Store in a cool and dry place, away from light.
Commercial Pack
Box containing 5 x 10 Tablets in blister pack.
Orion Laboratories Limited
Friday, November 14, 2008
A-Mycin (Erythromycin)
A·MYCIN (Erythromycin) Is a macrolide antibiotic which may be bactericidal or bacteriostatic. Erythromycin binds to the 50S ribosomal subunit of susceptible bacteria and suppresses protein synthesis without affecting nucleic acid synthesis.
A·MYCIN (Erythromycin) is usually active against following organisms: Gram'positive : Staphylococcus aureus, Streptococcus pyogenlis, S. pneumoniae, Corynebacterium diphtheriae, C. minutissimum. Gram·negative,.,Moraxella catarrhalis, Neisseria gonormoeae, Leglonella pneumophlla, Bor1!litella pertussis. Mycoplasma :
Mycoplasma pnaumoniae, Ureoplasma urealytlcum. Others : Chlamydia tlachomatis, Entamoeba histolytica, Treponema paliidum, Listeria monocytogenes.
Composition:
A·MYCIN Tablet: Each enteric coated tablet contains Erythromycin BP 250 mg.
A·MYCIN • 500 Tablet: Each enteric coated tablet contains Erythromycin BP 500 mg.
A·MYCIN Powder for Suspension : After reconstitution each 5 ml suspension contains Erythromycin Ethylsuccinate USP equivalent to 125 mg of Erythromycin.
A·MYCIN OS Powder for Suspension : After reconstitution each 5 ml suspension contains Erythromycin Ethylsuccinate USP equivalent to 250 mg of Erythromycin.
A-MYCIN Paedletrlc Drops: After reconstitution each 5 ml suspension contains Erythromycin Ethylsuccinate USP equivalent to 200 mg of Erythromycin.
Indications:
A·MYCIN is highly effective in the treatment of a wide variety of clinical infections,such as
Upper respiratory tract infections:Tonsillitis, peritonaillar abscess,pharyngitis,larynigitis,sinusitis,secondary infections in colds and influenza.
Lower respiratory tract Infactlons: Tracheitis, acute and chronic bronchrtis.Mycoplasma pneumonia (lobar pneumonia, broncho pneumonia, primary atypical pneumonia), bronchiectasis.
Skin and soft tlasue Infectlona: Boils and cartluncles,paronychia, abscesses, pustular acne, impetigo, cellulrtis, furuncolosis, erythrasma.
Venereal Infections: Non-specific urethritis, syphilis (if the patient is allergic to penicillin)
Gastro-Intestinal Infections : Cholecystitis, Staphylococcal enterocolrtls, Infectious diarrhoea & cholera.
Ear and oral Infections: Otitis media and otitis externa, gingivitis, dental abscesses.
Prophylaxis: Pre-operative and post-operative, trauma, burns, rheumatic fever.
Other Intections: Diphtheria, whooping cough.
Dosages & Admlnlatratlon:
Adults: Usually 250 mg every 6 hours, or 500 mg every 12 hours. May increase up to 4 g/day, according to severrty of infeclion.
Infections with Dosages and Admlnlatratlon is Describe Bellow:
Uppar respiratory tract infactions :
250 to 500 mg 4 times a day for 10 days of mild to moderate severity
Lower respiratory tract infections:
250 to 500 mg 4 times a day for 10 days of mild to moderate severity
Respiratory tract lnfeclions due to Mycoplasma pneumoniae:
500 mg 6 hours for 5 to 10 days, treat severe infections for up to 3 weeks
Skin and soft tissue infections of mild to moderate severity:
250 to 500 mg 4 times a day for 10 days
Pelvic inflammatory diseases (PID), acute due to Neisseria gonorrhoeae:
500 mg 4 times a day for 10 to 14 days
Urogenital infaction during pregnancy caused by Chlamydia trachomatis:
500 mg 4 times daily for 7 days or 250 mg 4 times daily for 14 days
Urethral, endocervical or rectal Infections, uncomplicated:
500 mg 4 times daily for 7 days or 250 mg 4 times daily for 14 days
Non-gonococcal urethritis :
500 mg 4 times daily for at least 7 days
Neisseria gonorrhoeae: Uncomplicated urethral, endocervical or rectal infections end in panicillinase producing N. gonprrhoeae (PPNG):
Early syphillis (primary, secondary) or latent syphillis of <>
500 mg 4 times a day for 14 days
Severe or chronic diarrhoea:
500 mg 4 times a day for 7 days
Rheumatic fever:
250 mg 2 times dally
Bacterial endocarditis:
1 g 2 hours prior to procedures, then 500 mg 6 hours after initial dose
Acne:
500 mg twice daily for 3 months reduced to 250 mg twice daily for 3 months
Children: The usual oral dose is 30-50 mg/kg body weight par day in divided doses.For more severe infections, the dose may be doubled.
Adverse Effects:
Gastro-intestinal-abdominal cramp & discomfort, nausea, vomiting & diarrhoea. Hyparsensitivlty reaction may also be responsible for the hepatotoxicity sometimes in patients receiving A·MYCIN (Erythromycin) or its derivatives.
Precautions & Warnings:
All forms of A-MYCIN (Erythromycin) should be used with care in patients wrth existing hepatic impairment. It has been suggested that A·MYCIN (Erythromycin) should be used with care in patients with history of arrhythmias .
Drug Interactions:
A·MYCIN (Erythromycin) may decrease the clearance of theophylline causing increased theophylline serum level and potential toxicity. It may decrease the metabolism of carbamazepine, triazolam, hexobarbital and phenytoin causing increased serum levels and potential toxicity. A·MYCIN (Erythromycin) may decrease the clearance of warfarin and thus potentiate the hypoprothrombinic effect of warfarin.
Use In Pregnancy and lactation:
Erythromycin is a pregnancy category B drug. Erythromycin Is considered compatible with breast feeding by the American Academy of Paediatrics.
Contraindications:
A·MYCIN (Erythromycin) is contraindicated in patents wrth known hypersensrtivity of this antibiotic.
Storage:
Store In a cool, dry place & away from light. Keep out of the reach of children.
Packing:
A·MYCIN Tablet: Box containing 5x10'sl10x10's tablet in blister pack.
A·MYCIN - 500 Tablet: Box containing 3x10's/5x10's in tablet blister pack.
A·MYCIN Powder for Suspension : Bottle containing dry powder for reconstitution of 100 ml suspension.
A·MYCIN DS Powder for Suspension : Bottle containing dry powder for reconstitution of 50 m1/100 ml suspension.
A·MYCIN Paediatric Drops: Bottle containing dry powder for reconstitution of 25 ml/ 50 ml/ 60 ml suspension with droppar.
Manufactured by :
ARISTOPHARMA LTD.
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