What should I avoid while taking Orogyl?
Do not drink alcohol or consume food or medicines that contain propylene glycol while you are taking Orogyl. You may have unpleasant side effects such as headaches, stomach cramps, nausea, vomiting, and flushing (warmth, redness, or tingly feeling).
Avoid alcohol or propylene glycol for at least 3 days after you stop taking this medicine. Check the labels of any medicines or food products you use to make sure they do not contain alcohol or propylene glycol
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.Medication: Orogyl (dose and duration not given) Pattern: Hepatocellular (R=62) Severity: 3+ initially (jaundice and hospitalization) 5+ on reexposure (liver transplantation, death) Latency:
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How long should I take it for?
It's very important to keep taking Orogyl for as long as your doctor has prescribed it.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects can include:
- Nervous system effects, including seizures and encephalopathy (abnormal brain function). Symptoms can include:
- convulsions (sudden movements caused by tightening of your muscles)
- ataxia (loss of control of body movements)
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Side effects for men vs. womenFor the most part, the side effects of Orogyl for men and women are the same. The only real differences in side effects affect women. For instance, Orogyl increases the risk of yeast infections, which occur much more often in women. Also, Orogyl can cause vaginal irritation and discharge.
Orogyl oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with Orogyl are listed below.
- Hypersensitivity to Orogyl or other nitroimidazoles (although cautious desensitization has been applied)
- Pregnancy, 1st trimester (controversial)
- Use of disulfiram within past 2 weeks; use of alcohol during therapy or within 3 days of discontinuing therapy
Effects of Drug Abuse
- No information available
- See "What Are Side Effects Associated with Using Orogyl?"
- Encephalopathcy, seizures, aseptic meningitis, and neuropathies reported with increase in dose and chronic therapy
- Superinfection may occur with prolonged use
- See "What Are Side Effects Associated with Using Orogyl?"
- Encephalopathy, seizures, aseptic meningitis, and neuropathies reported with increase in dose and chronic therapy
- Superinfection may occur with prolonged use
- Severe hepatic impairment; administer lower doses with caution
- Use with caution; potential accumulation in end stagerenal disease; supplemental doses may be needed in patients receiving hemodialysis
- Use with caution in history of blood dyscrasias, heart failure, hepatic failure, H. pylori infection, renal impairment
- Avoid alcohol while taking medication and for at least 1 day after discontinuation
- Antiandrogen: May cause gynecomastia
- Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Orogyl Injection and requires treatment with a candicidal agent
- Orogyl may be acceptable for use during pregnancy. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. There are published data from case-control studies, cohort studies, and 2 meta-analyses that included more than 5000 pregnant women who used Orogyl systemically during pregnancy
- Many studies included first trimester exposures. One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to Orogyl in utero; however, these findings were not confirmed
- In addition, more than 10 randomized, placebo-controlledclinical trials that together enrolled over 5000 pregnant women assessed the possible effect of systemic antibiotic treatment (including with Orogyl) for bacterial vaginosis on the incidence of preterm delivery; most studies did not show an increased risk of congenital anomalies or other adverse fetal outcomes following Orogyl exposure during pregnancy
- Three studies conducted to assess the risk of infantcancer following systemic Orogyl exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited.
- Orogyl is excreted in human milk; it is not recommended for use while breastfeeding
- Following oral administration, concentrations in human milk are similar to concentrations in plasma
- Potential for tumorigenicity shown in animal studies; a decision should be made whether to discontinue nursing or to discontinue Orogyl; breastfeeding women may choose to pump and discard milk for the duration of therapy and for 24 hours after therapy ends and to feed her infant stored human milk or formula
There are no adequate and well-controlled studies of in pregnant women; there are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used Orogyl during pregnancy; many studies included first trimester exposures; one study showed increased risk of cleft lip, with or without cleft palate, in infants exposed to Orogyl in utero; however, these findings were not confirmed
Orogyl crosses placental barrier and its effects on human fetal organogenesis are not known; reproduction studies have been performed in rats, rabbits and mice at doses similar to maximum recommended daily dose based on body surface area comparisons; there was no evidence of harm to fetus due to Orogyl; healthcare provider should carefully consider potential risks and benefits for each specific patient before prescribing therapy
How it works
Orogyl belongs to a class of drugs called nitroimidazole antimicrobials. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Antimicrobials are drugs used to treat infections. Nitroimidazole antimicrobials treat infections caused by bacteria and other organisms called protozoa. Orogyl tablets work by killing the bacteria or other organism that’s causing the infection. This relieves the infection.
Orogyl oral tablet doesn’t cause drowsiness, but it can cause other side effects.
Anaerobic Bacterial Infections
In the treatment of most serious anaerobic infections, intravenous Orogyl is usually administered initially.
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.
The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
10. Cautions with other medicines
Orogyl cream or gel isn't known to cause any problems with other medicines. However, there are some medicines that don't mix well with the tablets, suppositories, liquid or vaginal gel.
Tell your doctor before you start taking Orogyl tablets, suppositories, liquid or vaginal gel if you're taking these medicines:
- a blood thinner called warfarin
- lithium (used to treat some types of mental health problem)
- disulfiram (used to help people stay off alcohol)
- phenytoin or phenobarbitone (used to treat epilepsy)
- ciclosporin (used to dampen the immune system)
- fluorouracil or busulfan (used to treat some types of cancer)
- any medicines that you take as a liquid, in case these contain alcohol
How long should I use it for?
It's very important to keep using Orogyl cream or gel for as long as your doctor has prescribed it.
Orogyl has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Orogyl should not be administered concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to Orogyl are available, and concomitant administration with busulfan is medically needed, frequent monitoring of busulfan plasma concentration should be performed and the busulfan dose should be adjusted accordingly.
What if I forget to use it?
If you forget to use Orogyl vaginal gel, use it as soon as you remember, unless it is nearly time for your usual dose. Do not use it more than once a night. Then continue to use the gel at the usual time.
Despite the wide use of Orogyl, only rare cases of hepatotoxicity have been reported, and Orogyl is not listed among causes of drug induced liver injury and acute liver failure in large case series. High doses of Orogyl given parenterally or in an overdose can cause elevations in serum aminotransferase levels, but these are usually self-limited and minimally symptomatic (Case 1). Acute, clinically apparent liver injury from Orogyl is rare. Ornidazole, another synthetic nitroimidazole that was available in Europe, was implicated in several cases of drug induced liver injury, with a latency of a few days or weeks and a hepatocellular pattern of injury. Orogyl has been associated with a similar acute hepatitis-like syndrome with a short incubation period, but much more rarely. Fever, rash and eosinophilia are uncommon as are autoimmune features. A fatal recurrence of acute liver injury after reexposure to Orogyl has been published (Case 2). Strikingly, multiple instances of Orogyl hepatoxicity have been reported in the rare genetic disease, Cockayne syndrome in which there is an absence or deficiency in an important DNA repair enyzme responsible for nucleotide excision repair. The cases were marked by a short latency (1 to 7 days) to onset of jaundice, a hepatocellular pattern of enzyme elevations and severe course with a high mortality rate.