What is Romilac?
Romilac is a nonsteroidal anti-inflammatory drug (NSAID). Romilac works by reducing hormones that cause inflammation and pain in the body.
Romilac is used short-term (5 days or less) to treat moderate to severe pain.
Romilac may also be used for purposes not listed in this medication guide.
Romilac indications
Carefully consider the potential benefits and risks of Romilac Tromethamine and other treatment options before deciding to use Romilac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Romilac 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 Romilac Tromethamine, and oral Romilac Tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of Romilac Tromethamine injection and oral Romilac 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 Romilac Tromethamine therapy is not to exceed 5 days.
Romilac 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 Romilac Tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Romilac Tromethamine injection and narcotics should not be administered in the same syringe.
How should I use Romilac?
Use Romilac spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Romilac spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Romilac spray refilled.
- Do not take Romilac 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 Romilac spray for more than 5 days. Romilac spray is not for the treatment of mild to moderate or chronic pain (eg, headache).
- Avoid contact with the eyes. If you get Romilac 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 Romilac spray. Discard each bottle within 24 hours of opening it, even if it still contains some unused medicine.
- If you miss a dose of Romilac 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 Romilac spray.
Uses of Romilac 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 Romilac may be beneficial for acute abortive treatment of migraine in patients with a history of episodic migraines for at least 1 year.
Romilac 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. Romilac 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)
Romilac dosage
Carefully consider the potential benefits and risks of Romilac tromethamine tablets and other treatment options before deciding to use Romilac 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 Romilac tromethamine and Romilac tromethamine tablets is not to exceed 5 days. In adults, the use of Romilac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of Romilac tromethamine.
Transition from IV or IM dosing of Romilac tromethamine (single- or multiple-dose) to multiple-dose Romilac 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 Romilac tromethamine and Romilac tromethamine tablets is not to exceed 5 days.
The following table summarizes Romilac tromethamine tablet dosing instructions in terms of age group:
| Patient Population | Romilac Tromethamine Tablets (following IV or IM dosing of Romilac tromethamine) |
| Age < 17 years | Oral not approved |
| Adult Age 17 to 64 years | 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day |
| Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg | 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day |
Romilac interactions
See also:
What other drugs will affect Romilac?
Romilac slightly reduces the plasma protein-binding of warfarin. In vitro studies indicate that at therapeutic concentration of salicylate, the binding of Romilac reduces from approximately 99.2-97.5%; representing a potential 2-fold increase in unbound plasma Romilac levels. Romilac has been reported to reduce the diuretic response to furosemide in normovolemic individuals by approximately 20%.
Concomitant administration of Romilac and probenecid results in decreased clearance of Romilac and significant increase in Romilac 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 Romilac also.
There have been reports of a possible interaction of Romilac and nondepolarizing muscle relaxants, which lead to apnea. Concomitant use of Romilac 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 Romilac and antiepileptic drugs (phenytoin, carbamazepine). There have been reports of hallucinations when Romilac is concomitantly used with psychoactive drugs (fluoxetine, thiothixene, alprazolam).
Laboratory Tests: Romilac inhibits platelet aggregation and may prolong bleeding time.
Food: Food reduces the rate but not the extent of absorption.
Romilac side effects
See also:
What are the possible side effects of Romilac?
Applies to Romilac ophthalmic: ophthalmic solution
In addition to its needed effects, some unwanted effects may be caused by Romilac 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 Romilac 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 Romilac 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
Romilac contraindications
See also:
What is the most important information I should know about Romilac?
Romilac Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to Romilac Tromethamine.
Romilac 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.
Romilac 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.
Romilac Tromethamine is contraindicated as prophylactic analgesic before any major surgery.
Romilac Tromethamine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Romilac Tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.
Romilac 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.
Romilac 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.
Romilac 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 Romilac Tromethamine and probenecid is contraindicated.
The concomitant use of Romilac Tromethamine and pentoxifylline is contraindicated.
Romilac Tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.
Active ingredient matches for Romilac:
Ketorolac in Bangladesh.
List of Romilac substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Rometran-K (Mexico) | |
| Ropain (Indonesia) | |
| Rotek (Bangladesh) | |
| Rotoket (Philippines) | |
| Samulgin 0.5% (Egypt) | |
| Sanagese (Peru) | |
| Sanoket (Bangladesh) | |
| Sauran (Paraguay) | |
| Sauran Forte (Paraguay) | |
| Scelto (Indonesia) | |
| Scelto / amp 10 mg/1 mL x 5's (Pharos) | $ 13.39 |
| Scelto 30 mg/1 mL x 5's (Pharos) | $ 19.59 |
| Sebapain (Mexico) | |
| Sinalgico (Argentina) | |
| Sinalgico SL (Argentina) | |
| Sirolac (Taiwan) | |
| Sirolac 30 mg/1 mL x 1 mL | |
| Sirolac 30 mg/1 mL x 2 mL | |
| Sprix Spray | |
| Staket | |
| Staket 30mg Injection (Xieon Life Sciences Pvt Ltd) | $ 0.29 |
| Sukerin (Taiwan) | |
| Sukerin 10 mg | |
| Sukerin 30 mg/1 mL x 1 mL | |
| Sukerin 30 mg/1 mL x 2 mL | |
| Sukerin Ophthalmic (Taiwan) | |
| Sukerin Ophthalmic 0.5 % x 5 mL | |
| Suketon (Taiwan) | |
| Suketon 30 mg/1 mL x 1 mL | |
| Suketon 30 mg/1 mL x 2 mL | |
| Supradol (Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Panama, Tunisia) | |
| Gel; Topical; Ketorolac Tromethamine 2% (Liomont) | |
| Injectable; Injection; Ketorolac Tromethamine 30 mg / ml (Liomont) | |
| Tablet; Oral; Ketorolac Tromethamine 10 mg (Liomont) | |
| Tablet; Sublingual; Ketorolac Tromethamine 30 mg (Liomont) | |
| Tablets; Oral; Ketorolac Tromethamine 10 mg (Liomont) | |
| Tablets; Sublingual; Ketorolac Tromethamine 30 mg (Liomont) | |
| Surpim (Bangladesh) | |
| Syndol (Bangladesh, Chile, Turkey) | |
| Injectable; Injection; Ketorolac Tromethamine 30 mg (Universal Medicare Ltd.) | |
| Tablet; Oral; Ketorolac Tromethamine 10 mg (Universal Medicare Ltd.) | |
| 10's (Universal Medicare Ltd.) | $ 1.43 |
| Syndol Aceclofenac B-cyclodextrin 100mg, Paracetamol 500 mg, Thiocolchicoside 4 mg. TAB / 10 (Universal Medicare Ltd.) | $ 1.43 |
| Syndol 500+100+4 Tablet (Universal Medicare Ltd.) | $ 0.14 |
| SYNDOL DS TABLET 1 strip / 10 tablets each (Universal Medicare Ltd.) | $ 2.85 |
| SYNDOL TABLET 1 strip / 10 tablets each (Universal Medicare Ltd.) | $ 1.73 |
| SYNDOL tab 10's (Universal Medicare Ltd.) | $ 1.43 |
| Syndol SL (Chile) | |
| T-Lac (India) | |
| T-Lac Benzalkonium Cl 0.02% w/v, Ketorolac trometamol 0.5% w/v EYE-DPS / 5ml | $ 0.45 |
| 5ml | $ 0.45 |
See 936 substitutes for Romilac | |
References
- PubChem. "ketorolac". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ketorolac". http://www.drugbank.ca/drugs/DB00465 (accessed September 17, 2018).
- MeSH. "Cyclooxygenase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Romilac are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Romilac. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
