Pharmacological properties
Pharmacodynamics.
Limenda is a combined antimicrobial drug, the effect of which is due to metronidazole and miconazole, which are part of it. Miconazole provides an antifungal effect, and metronidazole determines the antibacterial and antitrichomoniacal effect of the drug. Miconazole nitrate has a broad spectrum of action and is particularly effective against pathogenic fungi, including C. albicans. In addition, miconazole nitrate is effective against gram-positive bacteria. Metronidazole is an antibacterial and antiprotozoal agent. It is effective against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococci and Trichomonas vaginalis.
Pharmacokinetics. Absorption of miconazole nitrate through the vaginal wall is negligible (approximately 1.4% of the dose). The bioavailability of metronidazole when administered vaginally is 20% compared to its bioavailability when administered orally. Miconazole nitrate is not detected in blood plasma after vaginal administration of Limend suppositories. The equilibrium concentration of metronidazole in blood plasma is 1.6–7.2 mg/ml. Metronidazole is metabolized in the liver. Hydroxymetabolite is the active substance. T½ of metronidazole is 6–11 hours. Approximately 20% of the dose is excreted unchanged in the urine.
Limenda vaginal suppositories 750mg/200mg No. 7x1
Name
Limenda soup.vag. 750mg200mg per bl. in pack No. 7x1
Dosage form
Vaginal suppositories
Compound
One suppository contains active substances: metronidazole 750 mg, miconazole nitrate 200 mg, excipient vitepsol S55
Description
Suppositories are oval, yellowish-white in color
Pharmacotherapeutic group
Antiseptics and antimicrobials for the treatment of gynecological diseases. Antiseptics and antimicrobials for the treatment of gynecological diseases (excluding combinations with corticosteroids). Imidazole derivatives. Imidazole derivative combinations. ATX code G01AF20
Pharmacokinetics
The bioavailability of metronidazole when used intravaginally is 20% compared to oral administration. After vaginal administration, when equilibrium was reached, the concentration of metronidazole in plasma was 1.6-7.2 mcg/ml. Systemic absorption of miconazole nitrate with this route of administration is very low (approximately 1.4% of the dose), and miconazole nitrate was not detected in plasma. Metronidazole is metabolized in the liver. The hydroxyl metabolite is active. The half-life of metronidazole is 6-11 hours. Approximately 20% of the dose is excreted unchanged by the kidneys.
Pharmacodynamics
Limenda is a combined antimicrobial drug, the effect of which is due to the constituents metronidazole and miconazole. Metronidazole is an antimicrobial and antiprotozoal agent effective against Gardnerella vaginalis and anaerobic bacteria, including anaerobic streptococci and Trichomonas vaginalis. Miconazole nitrate has a wide spectrum of activity and is especially effective against pathogenic fungi, including Candida albicans; in addition, miconazole nitrate is effective against gram-positive bacteria.
Indications for use
- vaginal candidiasis
- bacterial vaginosis
- trichomonas vaginitis
- vaginitis caused by mixed infections.
Directions for use and doses
The drug is administered intravaginally, 1 suppository at night for 7 days. For recurrent vaginitis or vaginitis resistant to other types of treatment, the course of treatment can be increased to 14 days. Vaginal suppositories should be inserted deep into the vagina using the disposable finger tips contained in the package. For elderly patients over 65 years of age, no dosage adjustment is required.
Side effects
Rarely
- hypersensitivity reactions (skin rash)
- headache
- abdominal pain or cramps
- vaginal itching, burning and irritation of the vagina
Very rarely
- leukopenia
- increased fatigue, dizziness
- change in taste, constipation, dry mouth, metallic taste
- diarrhea, loss of appetite, nausea, vomiting
- movement disorders (ataxia), peripheral neuropathy (with long-term use of the drug and overdose), seizures
Contraindications
- hypersensitivity to the components of the drug
- severe liver dysfunction
- epilepsy
- porphyria
- first trimester of pregnancy and lactation period
Drug interactions
The combined use of Limenda with oral anticoagulants is observed to enhance the anticoagulant effect. When used together with phenytoin, a decrease in the concentration of metronidazole in the blood is observed while the concentration of phenytoin increases. When co-administered with cimetidine, the concentration of metronidazole in the blood may increase and the risk of developing neurological side effects may increase. Concomitant use with lithium may increase the toxicity of lithium. Limenda increases plasma concentrations of astemizole and terfenadine. Possible interaction of metronidazole with alcohol can cause disulfiram-like reactions. The results may change when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood.
special instructions
Cannot be taken orally. For intravaginal use only. Limenda is not recommended for use in virgins. It is necessary to avoid drinking alcohol during treatment and for at least 24-48 hours after the end of the course due to possible disulfiram-like reactions. Caution should be exercised when using suppositories simultaneously with contraceptive diaphragms and condoms due to possible damage to the rubber base of the suppositories. In patients with trichomonas vaginitis, simultaneous treatment of the sexual partner is necessary. The results may change when determining the level of liver enzymes, glucose (hexokinase method), theophylline and procainamide in the blood. Use in pediatrics Not recommended for children and adolescents under 18 years of age due to insufficient data on use in this age group. Pregnancy and lactation In the second and third trimester of pregnancy, the drug is prescribed only if other treatment methods are ineffective, taking into account the benefit/risk ratio. Breastfeeding should be stopped during treatment, since metronidazole passes into breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment. Features of the effect of the drug on the ability to drive a vehicle or operate potentially dangerous mechanisms. The drug does not affect the ability to drive vehicles or operate machinery.
Overdose
There are no data regarding overdose with intravaginal use of metronidazole. After insertion into the vagina, metronidazole can be absorbed in quantities sufficient to cause systemic effects. Symptoms: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy (including after prolonged use in high doses), leukopenia, darkening of urine. Treatment: in case of accidental ingestion, gastric lavage is necessary. There is no special antidote. Symptomatic and supportive therapy is recommended.
Release form and packaging
7 suppositories per blister pack made of PVC/PE. 1 or 2 contour strip packages together with a package of finger pads (7 or 14 pieces, respectively) and instructions for medical use in the state and Russian languages are placed in a cardboard pack.
Storage conditions
Store in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children!
Shelf life
3 years Do not use after expiration date.
Vacation conditions
from pharmacies By prescription
Side effects
The incidence of systemic adverse reactions is negligible due to the very low plasma levels of metronidazole with vaginal administration of the drug (2–12% compared with oral administration). miconazole nitrate can cause vaginal irritation (burning, itching), like all other antifungals containing imidazole derivatives used intravaginally (2–6%). these complaints quickly disappear with continued treatment. If severe irritation occurs, treatment should be discontinued.
Adverse reactions reported with systemic use of the active substances of the drug are listed below.
From the blood and lymphatic system: frequency unknown - leukopenia.
From the blood and immune system: frequency unknown - hypersensitivity reactions.
Mental disorders: infrequently - depression; rarely - mental disorders.
From the nervous system: rarely - ataxia, convulsions, dizziness, headache; frequency unknown - increased fatigue or weakness, peripheral neuropathy due to active and/or long-term therapy with metronidazole.
From the digestive tract: frequency unknown - changes in taste, metallic taste, nausea, vomiting, constipation, dry mouth, diarrhea, lack of appetite, abdominal pain or cramps.
Violation of the general condition and condition at the injection site: very often - vaginal discharge; often - vaginitis, vulvovaginal irritation, discomfort of the pelvic organs; infrequently - a feeling of thirst; rarely - a feeling of heat in the vagina, itching, irritation, rash; frequency unknown - local irritation and hypersensitivity, contact dermatitis.
Side effects such as inflammation of the oral mucosa, stomatitis, glossitis, pancreatitis, hot flashes are also possible; rash, which may be accompanied by fever; urticaria, angioedema, anaphylactic shock, pustular rash; encephalopathy (for example, confusion) and subacute cerebellar syndrome (for example, ataxia, dysarthria, gait disturbance, nystagmus, tremor), which may resolve after discontinuation of the drug, aseptic meningitis, psychotic disorders, confusion, hallucinations, diplopia, myopia, decreased visual acuity, changes in color perception, optic neuropathy/neuritis; agranulocytosis, neutropenia and thrombocytopenia, increased activity of liver enzymes (AST, ALT, ALP), cholestatic or mixed hepatitis and hepatocellular liver damage, sometimes with jaundice; Cases of liver failure requiring liver transplantation have been reported in patients treated with metronidazole and other antibiotics; increase in body temperature.
These side effects are rare because the concentration of metronidazole in the blood is significantly lower when administered intravaginally.
Limenda
For intravaginal use only! Do not swallow or otherwise administer!
Limenda is not recommended for use in virgins.
During the treatment period, it is recommended to abstain from sexual intercourse. In patients with trichomonas vaginitis, simultaneous treatment of the sexual partner is necessary.
It is necessary to avoid drinking alcohol during treatment and for at least 24-48 hours after the end of the course due to possible disulfiram-like reactions.
When treated with gynecological dosage forms containing miconazole, the effectiveness of latex protective devices (condoms or diaphragms) may be reduced. For this reason, Limenda should not be used at the same time as using a latex condom or latex diaphragm.
When using the drug, leukopenia may occur, so it is advisable to monitor the blood picture at the beginning and end of therapy.
If adverse reactions occur indicating hypersensitivity or irritation of the mucous membrane, treatment should be discontinued.
Cases of severe hepatotoxicity/acute liver failure, including fatal cases, have been reported very rapidly after initiation of treatment with systemic metronidazole-containing products in patients with Cockayne syndrome. Therefore, in this population, metronidazole should be used after a careful risk-benefit assessment and only in the absence of alternative treatment. Diagnosis of liver function should be carried out immediately before starting therapy, during and after completion until liver function is within normal limits or until baseline values are achieved. If liver function tests become significantly elevated during treatment, the drug should be discontinued. Patients with Cockayne syndrome should immediately report any symptoms of liver dysfunction to their doctor and stop taking metronidazole.
Possible effects on the activity of liver enzymes and the content of glucose in the blood (when determined by the hexokinase method), theophylline and procainamide.
Impact on the ability to drive vehicles and machinery:
Considering possible undesirable reactions, care must be taken when driving a car and working with potentially dangerous mechanisms.
special instructions
The patient should be warned not to drink alcohol during therapy and for 2 days after completion of treatment due to the possibility of reactions from the central nervous system that are similar to the effects of disulfiram.
High doses of the drug and long-term use can cause peripheral neuropathy and seizures.
The suppository base may interact undesirably with the rubber or latex from which contraceptive diaphragms and condoms are made, so their simultaneous use with suppositories is not recommended.
Sexual partners of patients with trichomonas vaginitis should also undergo treatment.
In case of renal failure, the dose of metronidazole should be reduced.
In severe liver failure, the clearance of metronidazole may be altered. Metronidazole may increase symptoms of encephalopathy due to its elevated plasma levels. Therefore, metronidazole should be used with caution in patients with hepatic encephalopathy. The daily dose for such patients should be reduced to 1/3.
For elderly people (over 65 years): the same recommendations as for other patients.
The drug is not recommended for use by virgins.
Do not swallow suppositories or use the drug by any route other than vaginally.
Use during pregnancy and lactation. Use in the first trimester of pregnancy is contraindicated. After the first trimester of pregnancy, Limenda can be used after weighing the risk/benefit ratio, as prescribed by a doctor and under his supervision.
While using the drug, you should stop breastfeeding, since metronidazole passes into breast milk. Breastfeeding can be resumed 1–2 days after the end of treatment.
Children. The drug is not recommended for use in children.
The ability to influence reaction speed when driving vehicles or working with other mechanisms. Compared with systemic use, absorption of metronidazole by vaginal administration is significantly lower. Dizziness, ataxia, and psychoemotional disorders may occur. If you have such symptoms, it is not recommended to drive vehicles or operate other machinery.
Limenda (Metronidazole/Miconazole) vaginal suppositories. No. 7 - Instructions
Compound
The main constituents are metronidazole and miconazole.
Also contains vitepsol S55.
Release form
The drug is in the form of suppositories for vaginal use. Supplied in packs of 7 pieces each.
pharmachologic effect
Limenda vaginal suppositories are a drug of combined action. The ingredients metronidazole and miconazole nitrate actively fight bacteria and protozoa such as trichomonas, as well as fungal infections.
Pharmacokinetics
The active components of suppositories are absorbed into the blood through the vaginal mucosa and excreted from the body through the kidneys and then through the urinary tract.
Indications for use
Suppositories are prescribed for trichomoniasis and vaginitis caused by various pathological bacteria.
The product is effective against candidiasis that affects the mucous membranes of the vaginal walls and fallopian tubes.
Contraindications
Suppositories are contraindicated in chronic and acute renal failure.
They should not be used for epilepsy and porphyria. And accordingly, suppositories are not prescribed in cases of hypersensitivity to the components of the drug, that is, allergies to them.
Side effects
As a rule, the side effects of the drug do not depend on the dosage and frequency of use. Typically, the effect of itching and burning occurs after the first suppositories are installed. These symptoms are fleeting.
Compatibility with other medications
The components of Limenda suppositories enhance the effect of anticoagulants.
Mental disorders are possible when interacting with Disulfiram.
If you use suppositories like Cimetidine at the same time, the nervous system will be disrupted.
Amiodarone and Pimozide in contact with Limenda increase the likelihood of heart failure.
The components of the suppositories prolong the effect of Fentanyl and Glimepiride.
During interaction with Trimetrexate, its toxic effect increases. Accordingly, the work of the bone marrow and its hematopoietic function are inhibited. Possible development of renal and liver failure and stomach ulcers.
When interacting with fentanyl, the duration of action of the opioid increases and doubles. The consequence of such exposure is disruption of the central nervous system and respiratory system.
Astimizole and Cisaprite are retained in the blood by the components of Limenda. In addition, the concentration of these substances increases dangerously. Blood during this reaction requires additional purification.
But all data on the influence of drug elements on the action of other drugs are subjective and extremely rare. In most cases, patients take several medications at the same time, without any special deviations or comments.
Application and dosage
The drug is prescribed by the doctor based on the results of tests and examination of the patient. Usually 1 candle per day is indicated. It is recommended to use the drug in the evening before bedtime.
The full course of treatment is 7 days. If the therapy is ineffective and inflammation begins again, suppositories are used for another week.
Overdose
To date, no cases of overdose have been reported.
special instructions
In cases where treatment is not carried out for the first time, resistance is possible, that is, the body becomes dependent on such drugs. Then the course is immediately 14 days. Repeated analysis is required after treatment.
Use during pregnancy and breastfeeding
Limenda can be used during pregnancy, but only as prescribed by a doctor and under his supervision. The only thing that is not recommended during treatment with the drug is breastfeeding. Breastfeeding can be resumed only after the body has completely cleared the components of the drug. This happens 3 days after using the last candle.
Impact on the ability to drive vehicles and operate machinery
No special precautions are required.
Terms of sale
As prescribed by the doctor.
Storage conditions
In a dry, cool place, with limited access for children.
Interactions
Due to the absorption of metronidazole, drug interaction reactions are possible when used simultaneously with certain substances and medications:
Alcohol: The interaction of metronidazole with alcohol may cause a reaction similar to the interaction with disulfiram.
Oral anticoagulants: the anticoagulant effect may be enhanced.
Phenytoin: The concentration of phenytoin in the blood may increase, the concentration of metronidazole in the blood may decrease.
Phenobarbital: decreased concentration of metronidazole in the blood.
Disulfiram: possible CNS effects (psychotic reactions).
Cimetidine: Blood concentrations of metronidazole may increase and the risk of neurotic symptoms may increase.
Lithium: Possible increased toxicity from lithium.
Astemizole and terfenadine: Metronidazole and miconazole slow down the metabolism of these drugs and increase their plasma concentrations.
An effect on the blood concentrations of liver enzymes, glucose (hexokinase method), theophylline and procainamide was also observed.
Acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon, warfarin: increase the risk of bleeding.
Amiodarone: increased risk of cardiotoxicity (QT prolongation, torsade de pointes, cardiac arrest).
Fluorouracil: increased levels of fluorouracil in the blood and increased toxicity.
Carbamazepine: increased concentration of carbamazepine in the blood.
Cyclosporine: increased toxicity of cyclosporine.
Metronidazole may increase plasma levels of busulfan, which may result in significant busulfan toxicity. It is necessary to monitor the level of prothrombin and international normalized ratio more often while using oral anticoagulants. It is recommended to adjust the dose of the oral anticoagulant when using metronidazole and for 8 days after its discontinuation.
Due to the absorption of miconazole nitrate, drug interaction reactions may occur when used simultaneously with certain substances and medications.
Acenocoumarol, anisindione, dicumarol, phenindione, phenprocoumon, warfarin: increased risk of bleeding.
Astemizole, cisapride and terfenadine: Miconazole slows the metabolism of these drugs and increases their plasma concentrations.
Cyclosporine: increased risk of cyclosporine toxicity (renal dysfunction, cholestasis, paresthesia).
Fentanyl: enhances or prolongs the effects of opioids (CNS depression, respiratory depression).
Phenytoin and fosphenytoin: increased risk of phenytoin toxicity (ataxia, hyperreflexia, nystagmus, tremor).
Carbamazepine: decreased metabolism of carbamazepine.
Glimepiride: enhanced hypoglycemic effect.
Oxybutynin: increasing the concentration of oxybutynin in the blood plasma and increasing its effect (dry mouth, constipation, headache).
Oxycodone: increased plasma concentrations of oxycodone and decreased clearance.
Pimozide: increased risk of cardiotoxicity (QT prolongation, torsade de pointes, cardiac arrest).
Tolterodine: increasing the bioavailability of tolterodine in individuals with deficiency of cytochrome P450 2D6 activity.
Trimetrexate: increased toxicity of trimetrexate (bone marrow depression, kidney and liver dysfunction, gastrointestinal ulcers).
Overdose
There is no data on overdose of metronidazole when administered intravaginally in humans. When administered into the vagina, metronidazole may be absorbed in sufficient quantities to cause systemic effects.
If a large amount of the drug accidentally enters the digestive system, an appropriate method of gastric lavage should be used, if necessary. Treatment is required in cases where 12 g of metronidazole has entered the digestive system. There is no specific antidote; symptomatic treatment is recommended. In case of an overdose of metronidazole, the following symptoms are observed: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, vertigo, paresthesia, convulsions, leukopenia, darkening of urine.
In case of an overdose of miconazole nitrate, the following symptoms are observed: nausea, vomiting, inflammation of the throat and mouth, anorexia, headache, diarrhea.
Note!
Description of the drug Limenda supp. vagina. No. 7 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
