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DRUGS & SUPPLEMENTS
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Pratham
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Pratham uses
Pratham consists of Azithromycin, Zinc.Azithromycin:
Pharmacological action
Pratham is a macrolide antibiotic of azalides group. Pratham (Azithromycin) inhibits RNA-dependent protein synthesis of sensitive microorganisms.
It active against gram-positive bacteria: Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes group A); gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Escherichia coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi, Neisseria gonorrhoeae, Campylobacter spp., Legionella pneumophila; anaerobic bacteria: Bacteroides fragilis.
Pharmacokinetics
Pratham (Azithromycin) rapidly absorbed from the gastrointestinal tract. Ingestion reduces the absorption of Pratham (Azithromycin). Cmax in plasma is reached after 2-3 hours. This medicine rapidly distributed in tissues and biological fluids. 35% of the Pratham (Azithromycin) is metabolized in the liver by demethylation. More than 59% is excreted in the bile in unchanged form, about 4.5% in the urine in unchanged form.
Why is Pratham prescribed?
Infectious-inflammatory diseases caused by microorganisms susceptible to Pratham (Azithromycin), including bronchitis, pneumonia, infections of skin and soft tissue, otitis media, sinusitis, pharyngitis, tonsillitis, gonorrheal and non gonorrheal urethritis and / or cervicitis, Lyme disease (borreliosis).
Dosage and administration
Dosage of Pratham is setted individually according to nosology, disease severity and sensitivity of the pathogen. Dosage for adults for oral administration is 0.25-1 g 1 time/day; for children - 5-10 mg/kg 1 time/day. The duration of administration is 2-5 days.
Pratham (Azithromycin) side effects, adverse reactions
Digestive system: nausea, vomiting, flatulence, diarrhea, abdominal pain, transient elevation of liver enzymes, rarely - cholestatic jaundice.
Allergic reactions: rarely - a skin rash, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Dermatological reactions: rarely - photosensitization.
CNS: dizziness, headache, rarely - drowsiness, weakness.
Hematopoietic system: rarely - leukopenia, neutropenia, thrombocytopenia.
Cardiovascular system: rarely - chest pain.
Urogenital system: vaginitis, rarely - candidiasis, nephritis, increased residual nitrogen urea.
Other: rarely - hyperglycemia, arthralgia.
Contraindications
Hypersensitivity to Pratham and other macrolide antibiotics.
Using during pregnancy and breastfeeding
Pratham (Azithromycin) crosses the placental barrier. Use in pregnancy only in cases where the intended benefits to the mother outweighs the potential risk to the fetus.
If necessary to use Pratham (Azithromycin) in the lactation period should solve the issue of termination of breastfeeding.
Special instructions
Pratham not recommended for use in patients with compromised liver function.
Pratham (Azithromycin) uses with careful with impaired renal function.
This medication should be taken at least 1 hour before or 2 hours after eating or taking of antacids.
Pratham (Azithromycin) drug interactions
Simultaneous administration of Pratham (Azithromycin) with these drugs and medications may has followed effects:
Zinc:
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Drug abuse and dependence
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
Pratham (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Pratham (Zinc) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
CONTRAINDICATIONS
None known.
WARNINGS
Direct intramuscular or intravenous injection of Pratham (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.
Severe kidney disease may make it necessary to reduce or omit chromium and Pratham (Zinc) doses because these elements are primarily eliminated in the urine.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
PRECAUTIONS
General
Do not use unless the solution is clear and the seal is intact.
Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Pratham (Zinc) from a bolus injection. Administration of Pratham (Zinc) in the absence of copper may cause a decrease in serum copper levels.
Laboratory Tests
Periodic determinations of serum copper as well as Pratham (Zinc) are suggested as a guideline for subsequent Pratham (Zinc) administration.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of Pratham 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pratham (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pediatric Use
Pregnancy Category C. Animal reproduction studies have not been conducted with Pratham chloride. It is also not known whether Pratham (Zinc) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pratham (Zinc) chloride should be given to a pregnant woman only if clearly needed.
Geriatric Use
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
None known.
DRUG ABUSE AND DEPENDENCE
None known.
OVERDOSAGE
Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Pratham (Zinc) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Pratham (Zinc) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending Pratham (Zinc) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).
Death resulted from an overdosage in which 1683 mg Pratham (Zinc) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of Pratham (Zinc) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Pratham (Zinc) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against Pratham (Zinc) toxicity.
DOSAGE AND ADMINISTRATION
Pratham (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Pratham (Zinc) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Pratham (Zinc).
For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
HOW SUPPLIED
Pratham (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).
Store at 20 to 25°C (68 to 77°F).
Revised: October, 2004
© Hospira 2004 EN-0488 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
10 mL Vial
Pratham (Zinc)
1 mg/mL
Pratham (Zinc) Chloride Inj., USP
Rx only
FOR I.V. USE ONLY AFTER DILUTION.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
Pratham pharmaceutical active ingredients containing related brand and generic drugs:
Pratham available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.