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COMPOSITION

Tramadol Injectable

TRAMADOL
INJECTABLE
100.0 mg / 2ml
50.0 mg / 1ml
Tramadol HCl
100.0 mg
50.0 mg
Excipient c.s.p.
2 mL
1 mL


INDICATIONS :


MASTER FARMA’s generic Tramadol is indicated for the short-term treatment of moderate to severe pain.

PHARMACOLOGICAL ACTION :


MASTER FARMA’s generic Tramadol is a centrally acting analgesic that works in the central nervous system by blocking the transmission of pain signals sent by the sensory nerves to the brain. Unlike many potent analgesics, tramadol therapeutic dose does not have a depressant effect on respiration, and its cardiovascular effect is neutral. In therapeutic doses, it has not shown to cause the side effects of other traditional centrally acting analgesics, such as inhibition of diuresis and toxic effects to internal body organs.

Tramadol is rapidly absorbed at gastrointestinal level. At a dose of 100 mg, the bioavailability is approximately 75% and its absorption is not significantly affected by food intake. Its link to plasma proteins is low, in the order of 20%, with liver biotransformation and renal excretion.


DRUG INTERACTIONS :

The concurrent use with any of the following substances may produce interaction, depending on the amount :
(Major clinical significance)
Alcohol.
Anesthetics.
Central Nervous System Depressants. (Caution is advised because the concurrent use with any of the above substances may increase the depressant effects of these drugs. However, a favorable effect on pain management may be achieved combining Tramadol with tranquillizers).
Carbamazepine. (Raises Tramadol metabolism significantly, perhaps through the induction of metabolic enzymes. Patients receiving chronic doses of carbamazepine may require increasing the recommended dose of Tramadol).
Monoamine oxidase (MAO) inhibitors.
PRECAUCIONES :

Pregnancy :
It has been shown that Tramadol crosses the placental barrier, hence, the use of Tramadol during gestation is not recommended.
Breast-feeding : Tramadol is distributed into breast milk, thus the use of Tramadol is not recommended during lactation.
Pediatrics : No data is available on the effects of Tramadol in patients 16 or younger, therefore, its safety and efficacy have not yet been established.
Geriatrics : The elderly are prone to renal function deterioration, and an adjutment in the dose of Tramadol may be required.

In cases of renal or hepatic impairment, reduce dose or avoid taking; do not use in patients with a history of epilepsy; not a substitute for opioid-dependent patients; not recommended for analgesia during potentially slight plans of general anesthesia.

CONTRAINDICATIONS :

This medication should not be used when the following medical problems exist, except in special circumstances :

Greater clinical significance.
Acute intoxication with alcohol, hypnotics, centrally acting analgesics and psychotropic drugs.
History of drug abuse or dependence, including alcoholism.

The risk-benefit ratio should be assessed in the following clinical cases :

Risk of paralytic ileus.
Acute abdominal pain (may hinder diagnosis).
Risk of increased intracranial pressure or head trauma. Tramadol may cause pupillary changes (miosis), and might affect respiration.
Deterioration of liver function.
Deterioration of kidney function.
Respiratory depression.
Sensitivity to opioids.
Sensitivity to Tramadol.


INCOMPATIBILITY :

None have been reported.

WARNINGS :

Its use is not recommended in children 16 or under. Use with caution in elderly patients. Administer with caution in patients with a history of seizures, treatment should be brief or intermittent. As with any potent analgesic, the possibility of drug-dependence after prolonged use cannot be excluded.

Do not use MASTER FARMA’s generic Tramadol for more than seven days, unless it is strictly necessary.

This medicine may hinder reflexes making it difficult to react fast and accurately to unexpected and sudden events.


SIDE EFFECTS :

Hypotension and occasionally hypertension, allergic reactions, amnesia, hallucinations, shortness of breath, tachycardia, bradycardia, frequent tremors, palpitations, decreased urinary frequency and / or retention, sweats, dizziness, nausea, vomiting, dry mouth, fatigue, drowsiness , constipation, dizziness, headache, itching, rash, urticaria, mood swings, hypothermia, euphoria, confusion, miosis, decreased libido and potency.

TREATMENT IN CASES OF OVERDOSE :

A specific antagonist treatment with Naloxone may be performed to reverse some of the symptoms of an overdose with Tramadol. Naloxone could cause a sudden attack, therefore, it should be administered with caution.
Diazepam may be administered to treat seizures that may be caused by the toxicity of Tramadol.
It is necessary to correct the patient’s electrolyte imbalance, and keep him / her hydrated and oxygenated to maintain vital functions.
Patients with confirmed or suspected intentional overdose should be referred to the Psychiatrist for consultation.

Note :
Hemodialysis is not recommended in these cases.

DOSE AND ROUTE OF ADMINISTRATION :
The treating physician should indicate the dose, duration and route of administration.

Usual dose for adults and adolescents :

MASTER FARMA’S GENERIC INJECTABLE TRAMADOL

Tramadol 50 mg (1 mL Vial)

Intramuscular, intravenous (slow) and intravenous infusion, subcutaneous. Individual dose of 1-2 vials every 4 hours. Should not exceed 8 vials per day.

Tramadol 100 mg (2 mL Vial)
Intramuscular, intravenous (slow) and intravenous infusion, subcutaneous. Individual dose of 1 vial every 4 hours. Should not exceed 4 vials per day.

Usual pediatric dose:

Children under 16 : Its safe use and efficacy have not yet been established.
Children 16 and older : Use usual dose for adults and adolescents.

CONDICIONES DE CONSERVACIÓN Y ALMACENAMIENTO :

Manténgase a temperatura ambiente entre 15 y 30° C en lugar fresco y seco.

PRESENTATION :

MASTER FARMA’S GENERIC INJECTABLE TRAMADOL ( 50 mg / 1 mL ) :
Boxes of 1, 25, and 100 vials.

MASTER FARMA’S GENERIC INJECTABLE TRAMADOL ( 100 mg / 2 mL ) :
Boxes of 1, 25, and 100 vials.

Sold under prescription

MASTER FARMA S.A.

Address:

Calle Mariano Odicio 490,
Miraflores,
Lima 18 - Perú

Phone:
+51 (1) 446 1250     
+51 (1) 242 5577

Fax:

+51 (1) 445 7701



Propiedad de MASTER FARMA S.A. ®-2006