Osytramadol 500 100 Tramadol Hydrochloride Capsules

OSYTRAMADOL 50/100 (TRAMADOL CAPSULES BP 50/100mg)

Composition, Mechanism of action, Onset of action, Duration of action, Adverse effects, Contraindications, Special precautions, Use in Pregnancy and lactation, Interactions, Indications, Dosage, Storage, Presentation, NAFDAC registration numbers, Marketer and Manufacturer of Osytramadol 500 100 Tramadol Hydrochloride Capsules Medicine for Pains.

 

Composition

Tramadol Hydrochloride BP 50/100mg.

Excipients Q.S

Capsule shell contains approved colour.

It is centrally acting synthetic analgesics compound that is neither derived from natural sources nor it is chemically related opiates.

 

Mechanism of action

It acts via Opiod receptors in CNS to produce analgesia. It has no abuse potential.

 

Onset of action

30 – 60 mins.

 

Duration of action

8 – 12 hours.

 

Adverse Effects

Nausea, vomiting and dizziness.

 

Contraindications

Along with Hypnotics, Alcohol and Psychotropic intoxication, Hypersensitivity.

 

Special Precautions

With alcohol, not to drive and operate machinery.

 

Use In Pregnancy and Lactation

Safety not established.

 

Interactions

Carbamazepine

A significant increase in Tramadol metabolism. Hypnotics, Tranquilizers and other CNS depressants: Sedative effects are potentiated.

MAO inhibitors

Fatal interaction occurs. Opiod analgesics like Buprenorphine, Butophanol and Pentazocine: May precipitate withdrawal symptoms.

Transquilizers

Analgesia is potentiated.

 

Indications

Moderate to severe acute or chronic pain and in painful diagnostic measures and surgery. Arthralgia, musculoskeletal pain, colics, low back pain, pain associated with fractures, dislocation, confusion and osteoarthritis.

 

Dosage

Adults

Oral: 50 to 100mg 2 to 3 times daily.

Do not exceed 400mg total daily dose.

 

Children

Not recommended for children below 14 years.

 

Storage

Store below 30oC. Protect from light.

 

Keep all medicine out of reach of children.

 

Presentation

Available in blister of 10 capsules in mono carton and 100 blisters of 10 capsules in one carton.

 

Osytramadol 50mg: Nafdac No. B4-0639.

Osytramadol 100mg: Nafdac No. B4-0640.

 

Marketed by

Ossy Adamu Pharmaceutical Company Limited

No. 1 Umunna Street, Odoakpu Onitsha,

Anambra State.

 

Manufactured in India by

Maxheal Laboratories Pvt. Ltd.

H.O. 401 Maxheal House, Bangur Nagar, Goregaon (W.)

Mumbai – 400 090

 

Factory: 2-7/80-85, Sursez Sachin, Dist. Surat,

Gujarat – 394230

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