Tramadol Hydrochloride 50 mg

Drug Classification : Alnalgesic ( Opioid )

Composition :

Each capsule contains 50 mg tramadol hydrochloride

Each ml injection contains 50 mg tramadol hydrochloride

Actions :

Tramadol hydrochloride is a synthetic, centrally active analgesic. The pharmacologic effects tramadol of tramadol result in part from agonist activity at oplate receptors. Tramadol binds stereospecifically at central nervous system receptors, then block of pain sensation and response. Tramadol inhibits neurotransmitter relieving from aferen nervous which is sensitive of stimulation, then inhibits pain impuls.

Indications :

Effective for the treatment of moderately severe acute and chronic pain, including postoperative.

Dosage and Administration :

-  Oral therapy

Adult and children 14 years of age and older.

Usual dosage : Single dose 50 mg, for continued relief 50 mg can be administered after 30 – 60 minutes as needed.

Maximum dosage 400 mg daily.

In patients with renal or hepatic impairment with creatinine clearance less than 30 ml/minute : 50 – 100 mg every 12 hours, not to exeed 200 mg daily.

-  Parenteral therapy

Adults and children 14 years of age and older

i.v. administration  : 100 mg ( 1 ampoule ), injected slowly or dilute in infuse solution.

i.m. administration : 100 mg ( 1 ampoule )

subcutataneous       : 100 mg ( 1 ampoule )

For continued relief 50 mg tramadol injection ( 1 ml ) can be administered after 30 – 60 minutes as needed. Adjustment dosage is needed to patients with renal or hepatic impairment. Maximun dosage 400 mg daily.

Precaution :

For long term therapy, tramadol may produce dependence the physician must be decide the therapeutic period. This drug should be used with caution in patient with head trauma, increased intracranical pressure, serious hepatic and renal function impairment, bronchus hypersecretion becaue may increase risk of spasm or shock.

Concomitant administration with CNS suppressing agents or a large doses may caused lung function decreases. Tramadol should be used during pregnancy only if the potential benefit justifies the potential rist to the mother an to the fetus. Because the drug is excreted when the tramadol is administered to a nursing woman. Tramadol may cause neurologic adverse effects, patient should be advised to be careful before operating an automobile or machinery. Respiration depression caused by tramadol overdosage can be neutralized by naloxone withdrawal symptom caused by morphine therapy.

Side Effects :

General side effects e.g. dizziness, sedation, fatigue, headache, pruritus, sweating, erythema, drymouth, nausea, vomiting, dyspepsia and obstipation.

Contraindications :

Patients hypersensitive to tramadol or oplate and patients treated by MAO inhibitor, intoxication acute with alcohol, hypnotic, analgesic or CNS agents.

Drug interactions :

Concomitant administration with central nervous system drug e.g. tranquilizer, hypnotic, may increase sedation and analgesic effect of tramadol.

Storage :

Keep in a cool and dry please

Presentation :

Tramadol 50 mg capsule, box of 5 strips @ 10 capsules

Tramadol 50 mg/ml injection, box of 25 ampoules @ 2 ml

MetforminTablet 500 mg

Drug Classification : Antidiabetic Agents
COMPOSITIONS :
Metformin Tablets, each tablet contains : Metformin HCI 500 mg.
Metformin Caplets, each tablet contains : Metformin HCI 850 mg.

PHARMACOLOGY :
Pharmacodynamics :

Metformin is oral antihyperlycemic drug used in the management of Type 2 diabetes mellitus. Is not chemically or pharmacologically related to the oral Sulfonylureass. Metformin improves glucose tolerance in Type 2 diabetes subjects, lowering both basal and postpandial plasma glucose. It’s pharmacologic mechanism of action are different those of Sulfolureas. Metformin decrease hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity ( increases peripheral glucose uptake and utilization ). Unlike Sulfolureass, Metformin does not produce hypoglycemia in either diabetic or nondiabetic subjects ( except in special circumstance, see Precaution ) and does not cause hyperinsulinemia.

Pharmocokinetics :
- Absorption
The absolute bioavailability of 500 mg Metformin given under fasting conditions is approximately 50-60 %. Food decrease the extent and slightly delays the absorption of Metformin.
- Distribution
Metformin is negligibly bound to plasma proteins in contrast to Sulfolureass, which are > 90 % protein bound.
- Metabolism
Metformin does not undergo hepatic metabolism ( no metabolites have been identified in humans ) nor biliary excretion.
- Excretion
Metformin is excreted unchanged in the urine.


INDICATIONS :

- Type 2 diabetes mellitus ( non-insulin-dependent diabetes ) who are either overweight of normal weight, and in whom diet has failed.
- Type 1 diabetes mellitus ( insulin-dependent diabetes ) combination with insulin.
- Adjuvant therapy in insulin-dependent iabets to reduce the dosage of insulin required.
- Solo therapy in primary or secondary Sulfonylurea failures.
- Combined therapy with Sulfonylurea.

DOSAGE AND ADMINISTRATION :
Adults :
- Metformin 500 mg : one 500 mg tab 3 times a day with meals or after meals
If needed the dose can be increased until 3 gram a day.
- Metformin 850 mg : one caplet 850 mg 2 times a day with meals or after meals.

CONTRAINDICATIONS :
- Renal disease or renal dysfunction ( eg. As suggested by serum creatinine level > 1.g mg/dl. [males], > 1.4 mg/dl. [females] or abnormal creatinine clearance ) which may also result from condition such as cardiovascular collapse ( shock ), acute myocardial infarction and septicemia.
- Congestive heart failure requiring pharmacologic treatment.
- Hypersensitivity to Metformin.
- Acule or chronic metabolic acidosis, including diabetic ketoaciodsis, with or without coma.
-
WARNING AND PRECAUTION :
- Care is advised in cases of renal insufficiency.
- While it is advisable that patients on long-term Metformin therapy have a prophylactic annual serum B12 evaluation, no case of pemicious anemia has been attributed to Metformin therapy > 15 years old of wide scale use.
- Because of possibility of hypoglycemia in combination therapy with Sulfonylurea or insulin, diabetic control should be monitored by blood sugar readinds.
- Metformin should be given cautiously in elderly patients, serious infections and traumatic condisitions.
- Safety and efficacy in children have not been established.

DRUG INTERACTIONS :
- Recent work has indicated the possibility of an onteractions between Metformin and certain anticoagulant.
- May cause hypoglycemiawith Sulfonylurea or insulin.
- Risk of lactic acidosis is increased by alcohol.
- Impairs absorption of vitamin B12.
- Reduced renal clearance if given with Cimetidine.

ADVERSE REACTIONS :
- Gastrointestinal symptoms ( eg. Diarrhea, nausea, vomiting, abdominal bloating, anorexia ) are the most common reactions to Metformin.
- Patient may complain of unpleasant or metallic taste.
- Lactic acidosis.

PRESENTATION :
- Metformin Tablet 500 mg……………….Box. 10 Blisters @ 10 tablets
- Metformin Caplet 850 mg……………….Box. 10 Blisters @ 10 caplets

STORE AT ROOM TEMPERATURES ( 25º – 30º ) AND DRY PLACES

Ondansentron Injection

Drug Classification : Antiemetics
Compositions :
Ondansentron film coated caplet 8 mg, each film coated caplet contains : Ondansentron HCL equivalent to Ondansentron 8 mg
Ondansentron injection, each ml conatains : Ondansentron HCL equivalent to Ondansentron 2 mg

Pharmacology :
Pharmacodynamics :
Ondansentron is a potent, highly selective 5-HT3 receptor antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5-HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5-HT3 receptors. Ondansntron biocks the initiation of this reflex. Activation of vagal afferents may cause a release of 5-HT in the area postrema, located on the floor of the 4th ventricle, and this also promote emesis through a central mechanism. Thus, the effect of Ondansentron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is due to antagonism of 5-HT3 receptors on neurons located both in the peripheral and central nervous system.

Pharmacokinetics :
- Aborption :
Following oral administration of Ondansentron, absorption is rapid with maximum plasma concentrations of about 30 ng/ml be attained approximately 1,5 hours after an 8 mg dose. Similar concentration are achieved with in approximately 10 minutes of an 4 mg dose. The absolute oral bioavailability os Ondansentron is approximately 60%. Equivalent systemic exposure is achieved following i.m. and i.v. administration. The disposition of Ondansentron following oral i.m and i.v. dosing is similar with a terminal elimination half life of about 3 hours.
- Distribution :Aborption :
A steady state volume of distribution of about 140L.
- Metabolism :
Plasma protein binding is 70 – 76%
- Excretion :
Ondansentron is cleared from the systemic circulation predominatly by metabolism with < 5% of a dose excreted in the urine. Indications : Management of nausea and vomiting induced by chemotherapy, radiotherapy and surgery. Dosage And Adminstration : Phrophylaxis os pst surgical nausea and vomiting : Initial dose is 8 mg orally given 1hr prior to anaesthesia followed by 20 further doses of 8 mg at 8 hourly intervals. Alternatively a single dose of 4 mg i.m. or slow i.v. injection. Preventive of nausea and vomiting due to chemotherapy : - Adults : • Very emotogenic chemotherapeutic agents eg. Cisplatin. Initially 8 mg by slow i.v. injection or infusion for 15 minutes before chemotherapy, then follwed by continuous infusion of 1mg/hours for 24 hours or injection of 8 mg by slow i.v. for 15 minutes at 4 hours intervals or also may be followed by 8 mg orally 2 times daily for < 5 days. • Less emetogenic chemotherapeutic agents eg. Cyclophosphamide 8 mg by slow i.v. injection or infusion for 15 minutes before chemotheraphy, then followed by 8 mg orally 2 times daily for < 5 days. • Nausea and vomiting due radiotherapy : 8 mg tablet 3 times daily 1 – 2 hours before radiotherapy. Duration of treatment depends on duration of radiotherapy. - Children > 4 years :
• 5 mg/ml i.v. for 15 minutes before chemotheraphy, followed by 4 mg orally every 12 hours for < 5 days. - Elderly : • Ondansentron can be well tolerated without dose adjustment in patients > 65 years old and no alleration of dosage, dosing frequency or route of administration are required.
- Patient with Impaired renal function :
• Dose adjustment is not required, dosing frequency or route of administration are required.
- Patient with Impaired liver function :
• Total daily dose should not exceed mg.


Contraindication :
- Patient with hypersensitivy to any componed of Ondansentron.

Warning And Precaution :
- Ondansentron should not be use during pregnancy, especially during the 1 st. trisemester, unless the expected benefit t the patient is throught to outweight any possible risk to the fetus.
- It is recommended that’s mther recelving Ondansentro should not breastfeed their babies.

Drug Interactions :
- Since Ondansentron is metabolized by cytochrome P-450 metabolic enzymes, inhibition or reduced activity of this enzyme change Ondansentron clearance and half life.
- In patients treated with potent inducers of CYP3A4 ( i.e. phenytoin, carbamazepine, and rifampicin ), the clearance of Ondansentron was increased and Ondansentron blood concentrations were decreased.

Adverse Reactions :
- Headache, a sensation of flushing or warmth in the head epigastrium and occasional transient, asymptomatic increases in aminotransferases, increase large bowel transit time and may cause constipation in samo patients.
- There have been rare reports of immediate hypersnsitivy reactions incliding anaphytaxis. Rare case of transient visual disturbances ( e.g blurred vision ) and dizziness have beeb reported during rapid i.v. administration of Ondansentron. There have been rare reports suggestive of involuntary movement disorders without definite evidence of persistent clinical sequelae.

Presentations :
- Ondansentron film coated cablet 8 mg : Box. 3 Blisters @ 10 coated caplet.
- Ondansentron Injection 2 mg/ml : Box. 5 ampoules @ 2 ml
Box. 5 ampoules @ 4 ml