Incepta Pharma

Incepta Pharma pharama and Cosmeceutical

01/09/2015

Gemix
G e m i f l o x a c i n 320mg
Composition
Each film coated tablet contains
Gemifloxacin (as Mesylate).........320mg
Gemix (Gemifloxacin) is a synthetic broad spectrum antibacterial agent for oral administration. Gemifloxacin is related to the fluoroquinolone class of antibiotics available as the mesylate salt in the sesquihydrate form. Chemically, gemifloxacin is (R,S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1pyrrolidinyl]-1 1-Cyclopropy-6-fluoro-1,4-dihydro-4oxo-1,8-naphthyridine-3-carboxylic acid (C18H20FN504CH4O3S.)
Its unique structure confers enhanced activity against gram +ve pathogens without significant compromising gram -ve & atypical pathogens activity as compare to other fluoroquinolones.
CLINICAL PHARMACOLOGY
Mechanism of Action
Gemix inhibits two specific anzymes, DNA gyrase and DNA topoisomerase IV, which aid in bacterial DNA replication. Gemix displays strong binding affinity at both of these target sites, which helps maintain high potency against resistant S, Pneumoniae, This dual targeting with Gemix is achievable at therapeutic drug levels.
Pharmacokinetics
The pharmacokinetics of Gemix are approximately linear over the dose range from 40mg to 640mg. There was minimal accumulation of Gemix following multiple oral doses up to 640mg a day for 7 days (mean accumulation ≤20%). Following repeat oral administration of 320mg Gemix once daily, steady-state is achieved by the third day of dosing.
Absorption and Bioavailability
Gemix is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations of Gemix were observed between 0.5 and 2 hours following oral tablet administration and the absolute bioavailability of the 320mg tablet averaged approximately 71% (95% CI 60%-84%). Following repeat oral doses of 320mg to healthy subjects, The mean ± SD maximal Gemix plasma concentrations (Cmax) and systemic drug exposure (AUC(0-24) were 1.61± 0.51µg/ml (range 0.70-2.62 µg/ml) and 9.93 ± 3.07 µg/ml (range 4.71-20.1 µg/ml). respectively. In patients with respiratory and urinary tract infections (n=1423), similar estimates of systemic drug exposure were determined using a population pharmacokinetics analysis (geometric mean AUC (0-24). 8.36 µg/ml; range 3.2-47.7 µg/ml. The pharmacokinetics of Gemix were not significantly altered when a 320mg dose was administered with a high-fat meal. Therefore Gemix tablet may be administered without regard to meals
Distribution
In vivo, plasma protein binding in healthy elderly and young subjects ranged from 55% to 73% and was unaffected by age. Renal impairment dose not significantly affect the protein binding of Gemix. The blood-to-plasma concentration ratio of Gemix wa 1.2:1 Gemix is widely distributed throughout the body after oral administration. Concentrations of Gemix in bronchoalveolar lavage fluid exceed those in the plasma. Gemix penetrates well into lung tissue and fluids. After five daily doses of 320mg Gemix concentrations in plasma, bronchoalveolar macrophages, epithelial lining fluid and bronchial mucosa at approximately 2 hours.
Tissues Concentration (Mean ±SD) Ratio vs Plasma (Mean ±SD)
Plasma 1.40(0.442)µg/ml -------
Bronchoalveolar Macrophages 107 (77)µg/g 90.54(106.3)
Epithelial Lining fluid 2.69(1.96)µg/mL 1.99(1.32)
Bronchial Mucosa 9.52 (5.15)µg/g 7.21(4.03)
Metabolism
Gemix is metabolized to a limited extent by the liver. The unchanged compound is the predominant drug-related component detected in plasma (approximately 65%) up to 4 hours after dosing. All metabolites formed are minor (

01/09/2015

Famclor
F a m c i c l o v i r 250mg
Composition
Each tablet contains
Famciclovir........250mg
Indications and Usage
Treatment of acute herpes zoster (shingles), treatment or suppression of recurrent genital herpes in immunocompetent patients, treatment of recurrent mucocutaneous, herpes simplex infections in HIV-infected patients, treatment of recurrent herpes labialis (cold sores) in immunocompetent patients.
Mode of Action
Famclor is an antiviral. it works by blocking reproduction of the virus.
Pharmcology
Converts to penciclovir, which inhibits viral DNA replication by interfering with viral DNA polymerase.
Pharmacokinetics
Absorption
Bioavailability is about 77%, Tmax is 0.9 h, AUC 0-∞ is 2.24 to 17.9 mcgh/mL depending on dose.Cmax is 0.8 to 6.6 mcg/mL depending on dose.
Distribution
Vd is about 1.08 L/kg;less then 20% bound to plasma proteins.
Metabolism
Route is the liver; deacetylated and oxidized to form inactive penciclovir metabolites.
Elimination
Plasma CI is about 36.6 L/h; about 75% is renally cleared. The t½ is about 2 to 3h.
Storage/Stability
Store Famclor at 25 Degree Centrigarde. breif storage at temprature 15-30 Degree Centrigarade is permitted. Store away from heat, moisture, and light. Keep Famclor out of the reach of Children and away from pets.
Drug Interactions
Digoxin
Famclor may increase digoxin serum concentration.
Probenecid or other drugs significantly eliminated by active renal tubular secretion
May increase famciclovir (penciclovir) serum concentrations.
Laboratory Test interactions
None well documented.
Adverse Reactions
Headache (39%); fatigue (5%); migraine,Paresthesia(3%);confusion, confusional state, delirium, disorientation, hallucinations, somnolence(postmaketing).
Pruritus (4%); rash (3%); serious skin reactions (Including erythema multiforme), urticaria (postmarketing).
Nausea (13%); diarrhea (9%); abdominal pain(8%); flatulence, vomiting(5%), Dysmenorrhea (8%)
Anemia, leukopenia, neutropenia, thrombocytopenia (postmarketing).
jaundice(postmarkeing).
Children
Safety and efficacy not established
Renal Function
Dosage adjustment is recommended when Creatinine Clearance is 60 mL/min or less.
Contraindications.
Famclor is contraindicated in patients with known hypersensitivity to the product, its components.
Presentation
Available in pack of 10 tablets

01/09/2015

Acetin
A c i t r e t i n 25mg
Composition
Each capsule contains
Acitretin...........25mg
(U.S.P.Specifications)
Indications
Acetin (Acitretin) is a second generation retinoid indicated for the treatment of severe psoriasis in adults i.e., Plaque Psoriasis, Guttate Psoriasis, Inverse Psoriasis, Pustular Psoriasis & Erythrodermic Psoriasis.
Other
Acetin is sometimes also used to treat Darier's disease; palmoplantar pustulosis; lichen sclerosus et atrophicus of the vulva; palmoplantar lichen nitidus; and lichen planus. It is also used to treat lamellar ichthyosis, Sjogren-Larsson syndrome; and bullous and nonbullous ichthyosiform erythroderma.
Dosage
Acetin therapy should be initiated at 25 to 50mg per day, given as a single dose with the main meal Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient's response to initial treatment. Relapses may be treated as outlined for initial therapy.
Contraindications And Warnings
For Female Patients
Acetin must not be used by females who are pregnant or who may become pregnant during therapy or at any time for at least 3 years after discontinuation of treatment. Acetin also must not be used by females of reproductive potential who may not use 2 effective forms of contraception (birth control) simultaneously for atleast one month before, during and for atleast three years after treatment. Two effective forms of contraception (birth control) are to be used simultaneously, even when one is a hormonal contraceptive. Patients should not self-medicate with St. John's Wort because of possible interaction with hormonal contraceptives. Prescribers must obtain negative results for 2 pregnancy tests before initiating treatment with Acetin. The first test is a screening test, the second is a confirmation test done during the first 5 days of the menstrual period immediately preceding Acetin therapy. For patients with amenorrhea, the second test should be done at least 11 days after the last act of unprotected sexual intercourse. Timing of pregnancy testing throughout the treatment course should be monthly or individualized based on the the prescriber's clinical judgment. Females must sign a Patient Information/Consent about the risks of birth defects. Acitretin is a metabolite of etretinate and major fetal abnormalities have been repoted with both drugs. Acitretin can interact with ethanol to form etretinate. Therefore, females of reproductive potential must not ingest ethanol during treatment and for 2 months after cessation of treatment. Before prescribing, please see complete pregnancy warning in the accompanying. complete product information. Females who have undergone treatment with etretinate must continue to follow the contraception requirements for etretinate.
For Male Patients
A amall amount of Acetin is present in the semen of male patients who take this medication. It is not known whether this small amount of medication can harm the fetus.
For male and female patients
Do not donate blood while taking Acetin and for 3 year after treatment.
Acetin may cause liver damage. Tell your doctor if you have or ever had liver disease.
Side Effects
Common side effects include; Chelitis, rhinitis, dry mouth, arthralgia, spinal hyperostosis, alopecia, skin peeling, dry skin, nail disorder, pruritus, erythematous rash, hyperesthesia, paresthesia, paronychia, skin atrophy, sticky skin, chapped lips, and alteration in lipids.
Less frequent, but potentially serious, adverse events include; hepatotoxicity, pancreatitis, and pseudotumor cerebri, as well as hyperostosis, bad headaches, nausea, vomiting, blurred vision; decreased vision in the dark, depression, yellowing of your skin, loss of appetite or dark urine, great thirst or hunger, shortness of breath, alteration in lipids with possible cardiovascular effects, and ophthalmologic effects.
Presentation
Acetin Capsules are available in Alu-Alu blister pack of 30's.

01/09/2015

Atractin-20
I s o t r e t i n o i n 20 mg
Composition:
Each capsule contians
Isotretinoin BP.......20 mg
The Product Complies with B.P Specifications
Indication
Severe forms of nodule-cystic acne resistant to previous therapy, particularly cystic acne and acne conglobate, espcially when the lesions involve the trunk.
Dosage
Therapy should be started with 0.5mg/kg daily. After about four weeks. dosage for the maintenance treatment should be adjusted with the range of 0.1-1.0 mg/kg daily to meet individual needs. The maximum dosage of 1mg/kg daily should be given for only a limited period of time.
Contraindications
Atractin-20 is highly teratogenic and must not be used by women who are pregnant. The same applies to the women of childbearing potential unless strict contraception is practised four weeks before, during, and one month after treatment. It must not be given to nursing mothers, hepatic and renal insufficiency, hypervitaminosism A, patients with excessively elevated blood lipid values, hypersensitivity to the drug, supplementary treatment with tetracycline, blood donation by patients who are being treated (one to two week) with Atractin-20 is contraindicated.
Precautions
Liver function should be checked. Serum lipids (fasting value) should also be checked. In diabetics frequent determination of blood glucose level is recommended.
Side Effects
Muscle and joint pain, Bone changes and hyperostosis in children (i.e., premature epiphyseal closure) in adults treated over long periods with high doses of Atractin-20. Psychic or CNS disturbances, Hyperlipidemia, Hypertriglyceridemia, Dermatitus facialis, pyogenic granulosa, paronychia, increased formation of granulation tissue, Reversible alopecia. Intolerance to contact lenses, decreased night vision.
Interactions
Concurrent therapy with Atractin-20 and vitamin A must be avoid. As sympotms of hypervitaminosis A may be intensified.
Packs
Atractin capsules 20 mg, Pack of 30's Capsules.

Incepta Pharma was established in 2006-07, with a vision to extend and enhance human life & well being, by providing hig...
01/09/2015
Incepta Pharma

Incepta Pharma was established in 2006-07, with a vision to extend and enhance human life & well being, by providing highest quality pharmaceuticals, and has rapidly emerged as the premier integrated Marketing pharmaceutical company in Pakistan.
Its business focuses on the marketing of pharmaceutical products and services to clients across the pakistan,and its product & services portfolio includes both General and Dermatology products.
Within a little time period Incepta Pharma has become a leading Marketing Company in the field of Dermatology and has gained the confidence of prescribers across Pakistan
Specialties
Dermatology, Cosmetology, General
• Website
http://www.inceptapharmapk.com
• Industry
Pharmaceuticals
• Type
Partnership
• Headquarters
1177 B-Block Satellite Town Rawalpindi, Punjab 44000 Pakistan
• Company Size
51-200 employees
• Founded
2006

Offer innovative, high quality, cost effective products which contribute to the improvement of health care standards and are beneficial and safe to use.Understand and satisfy our costumer's.....

Incepta Pharma
01/09/2015

Incepta Pharma

Address

D Block Satelite Town
Rawalpindi
78100

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