Tetralgin Uses

• Tetralgin indications
• Uses of Tetralgin in details
• Tetralgin description
• Tetralgin dosage
• Tetralgin interactions
• Tetralgin side effects
• Tetralgin contraindications

What is Tetralgin?

Tetralgin is a nonsteroidal anti-inflammatory drug (NSAID). Tetralgin works by reducing hormones that cause inflammation and pain in the body.

Tetralgin is used short-term (5 days or less) to treat moderate to severe pain.

Tetralgin may also be used for purposes not listed in this medication guide.

Tetralgin indications

Carefully consider the potential benefits and risks of Tetralgin Tromethamine and other treatment options before deciding to use Tetralgin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Acute Pain in Adult Patients

Tetralgin Tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of Tetralgin Tromethamine, and oral Tetralgin Tromethamine is to be used only as continuation treatment, if necessary.

The total combined duration of use of Tetralgin Tromethamine injection and oral Tetralgin Tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses. Patients should be switched to alternative analgesics as soon as possible, but Tetralgin Tromethamine therapy is not to exceed 5 days.

Tetralgin Tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the Tetralgin Tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Tetralgin Tromethamine injection and narcotics should not be administered in the same syringe.

How should I use Tetralgin?

Use Tetralgin spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tetralgin spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tetralgin spray refilled.
• Do not take Tetralgin spray by mouth. Use in your nose only.
• Before you use each bottle for the first time, you must prime it. Remove the clear plastic cover and the blue plastic safety clip. Hold the bottle at arm's length away from you. Using your index and middle fingers on the top of the bottle and your thumb on the bottom of the bottle, press down evenly and release the pump 5 times. The bottle is now ready to use.
• To use this nose spray, gently blow your nose. Sit up straight or stand and tilt your head forward slightly. Place the tip of the spray container into the nose. Be sure to point the container away from the center of your nose. Breathe gently through the nostril and squeeze the spray container. If your dose requires 2 sprays, repeat the process for your other nostril. Replace the clear plastic cover after each use.
• Do NOT use Tetralgin spray for more than 5 days. Tetralgin spray is not for the treatment of mild to moderate or chronic pain (eg, headache).
• Avoid contact with the eyes. If you get Tetralgin spray in your eyes, rinse it out with water. If eye irritation persists for more than 1 hour, contact your doctor.
• Each bottle contains 1 day's supply of Tetralgin spray. Discard each bottle within 24 hours of opening it, even if it still contains some unused medicine.
• If you miss a dose of Tetralgin spray and you are taking it regularly, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tetralgin spray.

Uses of Tetralgin in details

Use: Labeled Indications

Pain, moderate to moderately severe: Short-term (up to 5 days) management of moderate to moderately severe pain in adults that requires analgesia at the opioid level.

Off Label Uses

Migraine

Data from a prospective, randomized, double-blind, double-dummy, placebo and active comparator, crossover, non-inferiority trial suggests that intranasal Tetralgin may be beneficial for acute abortive treatment of migraine in patients with a history of episodic migraines for at least 1 year.

Tetralgin description

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Tetralgin is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

Tetralgin dosage

Carefully consider the potential benefits and risks of Tetralgin tromethamine tablets and other treatment options before deciding to use Tetralgin tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of Tetralgin tromethamine and Tetralgin tromethamine tablets is not to exceed 5 days. In adults, the use of Tetralgin tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of Tetralgin tromethamine.

Transition from IV or IM dosing of Tetralgin tromethamine (single- or multiple-dose) to multiple-dose Tetralgin tromethamine tablets:

Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day

Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day

Note:

Oral formulation should not be given as an initial dose.

Use minimum effective dose for the individual patient.

Do not shorten dosing interval of 4 to 6 hours.

Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of Tetralgin tromethamine and Tetralgin tromethamine tablets is not to exceed 5 days.

The following table summarizes Tetralgin tromethamine tablet dosing instructions in terms of age group:

Tetralgin interactions

See also:
What other drugs will affect Tetralgin?

Tetralgin slightly reduces the plasma protein-binding of warfarin. In vitro studies indicate that at therapeutic concentration of salicylate, the binding of Tetralgin reduces from approximately 99.2-97.5%; representing a potential 2-fold increase in unbound plasma Tetralgin levels. Tetralgin has been reported to reduce the diuretic response to furosemide in normovolemic individuals by approximately 20%.

Concomitant administration of Tetralgin and probenecid results in decreased clearance of Tetralgin and significant increase in Tetralgin plasma levels (approximately 3-fold increase), and there is an increase of approximately 2-fold in terminal half-life.

Increase in plasma lithium concentration due to inhibition of renal lithium clearance has been reported with some NSAIDs. There have been some reports of increased lithium plasma levels with Tetralgin also.

There have been reports of a possible interaction of Tetralgin and nondepolarizing muscle relaxants, which lead to apnea. Concomitant use of Tetralgin and angiotensin-converting enzyme inhibitors may increase the risk of renal impairment, particularly in volume-depleted patients.

Very few cases of seizure have been reported with concomitant use of Tetralgin and antiepileptic drugs (phenytoin, carbamazepine). There have been reports of hallucinations when Tetralgin is concomitantly used with psychoactive drugs (fluoxetine, thiothixene, alprazolam).

Laboratory Tests: Tetralgin inhibits platelet aggregation and may prolong bleeding time.

Food: Food reduces the rate but not the extent of absorption.

Tetralgin side effects

See also:
What are the possible side effects of Tetralgin?

Applies to Tetralgin ophthalmic: ophthalmic solution

In addition to its needed effects, some unwanted effects may be caused by Tetralgin ophthalmic. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Tetralgin ophthalmic:

More common:

• Itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use
• redness of the clear part of the eye
• sensitivity to light
• swelling of the eye
• tearing
• throbbing pain

• Blurred vision or other change in vision
• eye irritation or redness

Minor Side Effects

Some of the side effects that can occur with Tetralgin ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Stinging or burning of the eye when medicine is applied

• Dry eyes
• headache

Tetralgin contraindications

See also:
What is the most important information I should know about Tetralgin?

Tetralgin Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to Tetralgin Tromethamine.

Tetralgin Tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.

Tetralgin Tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Tetralgin Tromethamine is contraindicated as prophylactic analgesic before any major surgery.

Tetralgin Tromethamine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Tetralgin Tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.

Tetralgin Tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.

Tetralgin Tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding.

Tetralgin Tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.

The concomitant use of Tetralgin Tromethamine and probenecid is contraindicated.

The concomitant use of Tetralgin Tromethamine and pentoxifylline is contraindicated.

Tetralgin Tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.

Active ingredient matches for Tetralgin:

Ketorolac in Argentina, Paraguay.

Caffeine/Chlorphenamine/Ergotamine/Metamizole/Metoclopramide in Argentina.

Caffeine/Chlorpheniramine Maleate/Dipyrone/Ergotamine Tartrate/Metoclopramide Hcl

References

1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
3. PubChem. "ERGOTAMINE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology