Doloran PRT Tablet (Prolonged Release)

Introduction

Tramadol hydrochloride is a synthetic opioid analgesic used to manage moderate to moderately severe pain. It is typically used for both acute pain and chronic pain. It is sold under brand names such as Ultram, Rybix, and Conzip, and generic formulations.

Uses for

Tramadol is most commonly used for acute and chronic pain relief. It can be used to treat moderate to severe pain associated with:

Arthritis
Back pain
Fibromyalgia
Cancer
Migraine Headaches
Neuropathic Pain

Mechanism Of Action

Doloran PRT Tablet (Prolonged Release) 100 mg works as a µ-opioid receptor agonist, similarly to other opioids such as heroin, morphine, or codeine. However, the mechanism of action with Tramadol is unique in that it not only affects the µ-opioid receptors but also inhibits the reuptake of serotonin and noradrenaline.

How Long Does It Take To Work

Doloran PRT Tablet (Prolonged Release) 100 mg typically takes approximately 20-30 minutes to take effect. This may vary depending on the individual, however, with the average being 20-30 minutes.

Absorption

Tramadol hydrochloride is rapidly absorbed in the gastrointestinal tract. Maximum concentrations are observed 2-3 hours after administration.

Route Of Elimination

Tramadol hydrochloride is metabolized in the liver and then excreted primarily in the urine. Some of the drug is also excreted in the feces. The elimination half-life is approximately 6-7 hours.

Dosage

Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.

Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.

Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.

Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.

The dose of tramadol hydrochloride will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tramadol hydrochloride. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules, tablets):

Adults—25 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose if needed. However, the dose is usually not more than 400 mg per day. For children—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 mg per kilogram (kg) of body weight every four to six hours as needed. The dose is usually not more than 8 mg per kg per day.

Administration

Tramadol hydrochloride should be taken with food or a full glass of water to avoid stomach upset. It can be taken with or without food, but if taken with food it may take longer for the drug to take effect.

Side Effects

The most common side effects of tramadol hydrochloride include drowsiness, nausea, vomiting, constipation, headache, dizziness, dry mouth, and sweating. If these effects persist or worsen, contact your doctor or healthcare professional promptly.

Toxicity

Tramadol hydrochloride has a low risk of overdose. Overdoses of tramadol can cause serious respiratory depression, loss of consciousness, and death. Signs of overdose include severe drowsiness, pinpoint pupils, slow and shallow breathing, and loss of consciousness.

Precautions

Before taking tramadol, tell your doctor or pharmacist if you are allergic to it; or to other opioids (e.g., codeine, hydrocodone); or if you have any other allergies.

Interactions

Tramadol hydrochloride may interact with other medications so it is important to tell your doctor about all other medications you are taking, including non-prescription medications, vitamins and supplements, herbal products, and any recreational drugs. Certain substances may increase the risk for side effects with tramadol, so ask your doctor about any potential interactions.

Disease Interaction

Tramadol hydrochloride use may worsen certain conditions such as seizures, depression, or asthma. Tell your doctor if you have any of these conditions so they can adjust your tramadol dosage.

Drug Interactions

Tramadol may interact with other medications so it is important to tell your doctor about all other medications you are taking, including non-prescription medications, vitamins and supplements, herbal products, and any recreational drugs. Certain substances may increase the risk for side effects with tramadol, so ask your doctor about any potential interactions.

Food Interactions

Tramadol hydrochloride can be taken with or without food. Eating a large or fatty meal may slow the absorption of the drug and can make it less effective.

Pregnancy Use

Tramadol hydrochloride is not recommended during pregnancy as it may cause harm to both the mother and unborn baby. Talk with your doctor about the risks before taking this medication.

Lactation Use

It is not known whether tramadol passes into breastmilk. As a precaution, breastfeeding women should not take Tramadol hydrochloride.

Acute Overdose

The signs and symptoms of tramadol hydrochloride overdose can include severe drowsiness, pinpoint pupils, shallow and slow breathing, and loss of consciousness. If an overdose is suspected, seek emergency medical attention immediately.

Contraindications

Doloran PRT Tablet (Prolonged Release) 100 mg is contraindicated in patients who have previously shown hypersensitivity to Tramadol or other opioid analgesics, patients with severe hepatic or renal impairment, patients with a history of alcohol or substance abuse, and pregnant women.

Use Direction

Doloran PRT Tablet (Prolonged Release) 100 mg should be taken as prescribed by your doctor. Do not exceed the recommended dosage or duration of treatment without consulting your doctor. Take the medication with food or a full glass of water to avoid stomach upset.