Periodically occurring pain and discomfort in the muscles and joints are familiar to almost every expectant mother. The female body does not always have time to adapt to the changes occurring in it, as well as increasing loads. The main “blow” is taken by the woman’s musculoskeletal system - the spine, joints, legs. The situation is even more aggravated if the woman, even before the “interesting situation,” experienced discomfort and pain in the back, joints and muscles of the legs.
During the period of bearing a baby, the intensity of discomfort increases significantly. If the pain is still moderate, of course, the doctor will recommend that the woman turn to methods of general relaxation and rest. When the pain is so acute that it disrupts the usual way of life, medications can be used. Nise gel is an effective means of relieving pain and reducing inflammation in muscles and joints. However, is it permissible to use this medication during gestation?
Nise gel - instructions for use during pregnancy
The drug Nise in gel form is an effective means for external treatment. The medicinal substance quickly relieves inflammation and also reduces pain. What components of the drug provided its therapeutic effect and will they be safe during gestation?
Composition and pharmacological action of Nise gel
The active compound in the clear yellow gel is nimesulide. The concentration of this substance in the drug is 1% (1 g of gel contains 10 mg of nimesulide). The therapeutic effect of the drug is enhanced by the presence of compounds such as methyl salicylate (at a concentration of 10%), menthol (5%) and capsiacin (0.02%).
The drug belongs to the non-steroidal anti-inflammatory drugs group. Intended for external use only. The medicine is designed to reduce the manifestations of inflammation, as well as effectively eliminate pain in the area of application. The main “field of activity” of the gel is muscles and joints. As a result of gel treatment, not only an improvement in well-being is achieved, but also an increase in the volume and amplitude of movements.
- Nimesulide. This substance belongs to the class of sulfonamides. It is its presence that causes a decrease in the intensity of inflammation and pain, as well as an antipyretic effect.
- Methyl salicylate is a derivative of salicylic acid. The compound inhibits the release of substances necessary for the synthesis of prostaglandins (they are the ones “responsible” for the appearance of swelling and pain at the site of inflammation). At the application site, methyl salicylate normalizes increased vascular permeability, microcirculation processes, and reduces swelling.
- Menthol produces an analgesic effect, accompanied by a feeling of slight coolness at the application site. The substance has a local irritating and distracting effect. The antiseptic property of menthol manifests itself in the total destruction of microbial cells. The compound also reduces itching (if any) and has a calming effect.
- Capsiacin provokes an irritating effect, as well as a local increase in blood circulation. The substance blocks the production and transmission of substance P along neurons, which leads to a decrease in pain.
Despite the external use of the gel, nimesulide still penetrates into the bloodstream through the skin, exerting a systemic effect, albeit insignificant. The presence of other components of the drug in plasma, as well as the metabolic product of nimesulide, 4-hydroxynimesulide, was not recorded.
Indications for use of Nise gel
Based on the action of the constituent components of the medicine, a list of conditions was determined for which the use of Nise gel is advisable. The product is recommended in case of lesions of the musculoskeletal system, which are accompanied by inflammatory processes and pain. The affected area can include both soft tissue and articular joints.
The drug can be used for:
- inflammatory and dystrophic processes in the tissues of tendons and ligaments (tendinitis, bursitis);
- sprains;
- pain in the lower back;
- arthritis;
- arthrosis;
- osteochondrosis;
- sciatica (inflammation of the sciatic nerve);
- myalgia of rheumatic and non-rheumatic origin;
- inflammatory processes in soft tissues as a result of injuries.
It is worth noting that the therapy is symptomatic, although it helps with both acute and chronic lesions. The use of the drug involves uniform application of the gel to a washed and dried area of the skin - the site of greatest pain. Do not rub the product in.
Contraindications to the use of Nise gel
Despite the external use of the medicine, Nise in gel form also has restrictions on its use. These include:
- Pregnancy period. According to the annotation for the drug, Nise is prohibited for use in such a category as pregnant women, regardless of the form of release.
- Increased personal reaction to any of the components of the drug.
- Dermatitis, as well as skin lesions of an infectious nature.
- Allergic skin rashes.
- It is forbidden to apply the gel to mucous membranes and wound surfaces.
- A history of negative reactions to the use of any NSAID drug or acetylsalicylic acid.
With topical use of the drug Nise, practically no negative reactions are observed. In some cases, at the site where the gel is applied, the following is possible:
- Redness.
- Itching and rashes.
- Burning sensation.
Systemic reactions are possible only if the drug covers large areas of the dermis. The occurrence of any side effect is a reason to discontinue the drug and seek medical advice.
Nise gel 20g No. 1
Name
Nise Gel gel d/nar.approx. 10mg/1g in tubes 20g in pack. No. 1
Description
White or almost white gel, free of visible inclusions.
Main active ingredient
Nimesulide
Release form
A tube containing 20 g of gel, made of PE/Ethylene acrylic acid/aluminum foil with a polypropylene cap, is packed in a cardboard box with instructions for use.
Dosage
10mg/1g in tubes 20g in pack. No. 1
Pharmacodynamics
The main effects of NICE GEL are due to the action of the components included in its composition. Nimesulide? a non-steroidal anti-inflammatory drug belonging to the sulfonamide class. Selectively inhibits cyclooxygenase-2 (COX-2), thereby reducing the synthesis of prostaglandins (PGs)? main mediators of inflammation and pain. Nimesulide inhibits the production of platelet activating factor, tumor necrosis factor alpha, the release of proteinases and histamine. Methyl salicylate? salicylic acid derivative? has a local anti-inflammatory and distracting effect. Menthol has an analgesic effect, which is accompanied by a feeling of cold. The analgesic effect of menthol is associated with stimulation of cold receptors in the skin. Capsaicin has a local irritant effect, causes a local increase in blood flow and tissue hyperemia at the site of application, and promotes the release of endogenous biologically active substances.
Pharmacokinetics
Nimesulide: according to international studies, the maximum concentration of nimesulide in blood plasma after a single local application at a dose of 200 mg is observed 24 hours after application and reaches 9.77 ng/ml. Metabolized in the liver. No traces of the main metabolite nimesulide? 4-hydroxynimesulide was not detected in plasma. With long-term use, the concentration of nimesulide on day 8 in the blood plasma was 37.25 ± 13.25 ng/ml, which is 100 times less than when taken orally at an average daily dose (200 mg/day). Due to insignificant systemic absorption, data on the pharmacokinetics of the remaining active components when applied topically are not available.
Indications for use
? as an adjunct in the complex treatment of diseases of the joints and soft tissues of an inflammatory nature (osteoarthritis, periarthritis, tendonitis, tenosynovitis), and for pain in the lower back. ? stretching of muscles and ligaments. Dosage regimen and method of use For external use only. The gel (in an amount corresponding to the length of a column of 3 cm) is carefully applied in a thin layer to the painful area 3? 4 times daily or as directed by a physician. Rinse thoroughly and dry the skin area before application. Apply a thin layer of gel to the corresponding area and surrounding area, rub in with light movements. It is recommended to avoid wearing constrictive clothing. Before and after the procedure, wash your hands with soap. It is not recommended to use more than 1 tube per day (5 mg/kg). Usually the course of treatment lasts 7? 15 days. If necessary, repeated courses of treatment are recommended after 3? 5 days. Warnings and precautions If local irritative reactions occur, the use of the drug should be suspended and appropriate treatment measures taken. Do not apply the gel to mucous membranes, eyes, damaged and infected areas of skin, areas affected by skin diseases and open wounds. During application, an intense burning sensation may occur, which disappears within a few days. Do not touch sensitive areas of the skin during the procedure and until your hands are cleansed of drug residues. The gel should be used with caution in patients at risk of developing adverse reactions caused by salicylates. It is not recommended to use this medication immediately before, during, or after activities that increase body and skin temperature (eg, bathing in hot water, swimming, sunbathing, strenuous exercise), or in hot or humid weather. It is recommended to wait until the skin cools down to normal temperature and normal sweating is restored. You should not use the drug before visiting a solarium or being under direct or indirect sunlight; it is not recommended to warm up the area where the gel is applied. There have been reports of skin burns following the use of topical products containing methyl salicylate, capsaicin and menthol.
Directions for use and doses
Externally. Before applying the gel, wash and dry the surface of the skin. Apply a uniform thin layer of gel approximately 3 cm long to the area of maximum pain, without rubbing, 3-4 times a day. The amount of gel and the frequency of its use (no more than 4 times a day) may vary depending on the size of the treated area and the patient’s response. The gel should not be used for more than 10 days without consulting a doctor.
Use during pregnancy and lactation
Contraindicated during pregnancy and lactation.
Precautionary measures
Liver failure; renal failure; severe heart failure; arterial hypertension; diabetes mellitus type 2; old age, childhood.
Interaction with other drugs
The drug causes skin hyperemia and reflexively increases blood circulation in the subcutaneous tissue, thus, combined use with other local drugs can lead to increased absorption. Use of large quantities may increase the toxicity of methotrexate and reduce the therapeutic effectiveness of hypoglycemic agents. The drug should not be used with oral anticoagulants. The drug should not be used together with other drugs for topical use. It is not recommended to use the gel simultaneously with other non-steroidal anti-inflammatory drugs. Glucocorticosteroids and antirheumatic drugs (gold preparations, aminoquinolones) enhance the effect of the drug. Pharmaceutical information
Contraindications
Pregnancy and lactation. Dermatoses, damage to the epidermis, skin infections in the area of application. Established hypersensitivity to nimesulide and other components of the drug. Children under 18 years of age. It is recommended to use with caution in case of erosive and ulcerative lesions of the gastrointestinal tract, liver failure, renal failure (creatinine clearance less than 30 ml/min), congestive heart failure, arterial hypertension, “aspirin” asthma, type 2 diabetes mellitus (non-insulin-dependent). Epilepsy, history of seizures (including febrile). Features of use Do not apply the gel around the eyes, on mucous membranes, on healthy areas of the body, or on wound surfaces. Do not use for dermatitis. Do not touch sensitive areas of the skin with your hands containing the gel. Avoid using the gel with airtight dressings. After applying the gel, wash your hands with soap. After completely rubbing the drug in, redness and burning may occur. These symptoms usually go away within a few days after stopping the drug. The drug should be used with caution in patients with an increased risk of developing side effects associated with taking salicylates. Use in pregnant and lactating women Nimesulide is not used in pregnant and lactating women. Studies confirming its effectiveness and safety during pregnancy and lactation have not been conducted. There is no data on the effect on fetal development. Use in pediatrics Indications and recommendations for use in children are not known. Effect of use in drivers and workers associated with machinery. Patients taking nimesulide orally should be warned about its side effects? dizziness. Use with caution while driving and working. There were no cases of dizziness after topical use of nimesulide. Mutagenicity and carcinogenicity In various studies, nimesulide turned out to be a non-mutagenic drug. There is also no data on the effect of the drug on the chromosomes of lymphocytes in vitro, and the interaction with H-thymidine of cultured human lymphocytes.
Compound
1 g nimesulide 10 mg Excipients: N-methyl-2-pyrrolidone - 250 mg, propylene glycol - 100 mg, macrogol - 315.5 mg, isopropanol - 100 mg, purified water - 200 mg, carbomer 940 - 20 mg, butylated hydroxyanisole - 0.2 mg , thiomersal - 0.1 mg, potassium dihydrogen phosphate - 0.2 mg, flavoring (Narcissus-938) - 4 mg.
Overdose
No cases of overdose with local use have been described. When applying more than 50 g to large areas of skin, an overdose (systemic adverse reactions) may develop. It is recommended to consult a doctor. There are no specific antidotes.
Side effect
Topically applied nimesulide preparations are usually well tolerated. Observed side effects include moderate or severe local irritative reactions, hyperemia, rash, desquamation, itching and associated reactions in the area of application of the drug, as a manifestation of hypersensitivity to the components of the drug. Capsaicin, which is part of the drug, in a concentration of 1% or more can cause neurotoxicity and thermal hyperalgesia, a burning sensation, and redness. If adverse reactions occur, you must stop using the drug and prescribe appropriate treatment. No systemic adverse reactions were observed when using the drug. Photosensitivity may develop. Mild changes in skin color and allergic reactions have also been reported. In rare cases, sensitive patients developed anaphylactic reactions, such as Quincke's edema, vasomotor rhinitis, shortness of breath, bronchospasm.
Storage conditions
Store in a place protected from light at temperatures up to 25 °C. Do not freeze. Keep out of the reach of children.
Is it possible to use Nise gel during pregnancy?
As the instructions for the Nise gel inform, the use of the drug during the period of gestation is not allowed. What is the reason for such a ban? What threats does the use of the gel pose during gestation?
Nise gel during pregnancy - 1st trimester
Already from the first days after successful fertilization and implantation of the embryo into the uterine wall, close contact begins between the woman’s body and the new life developing in her womb. For this reason, almost all chemical compounds that enter the body of a pregnant woman in the first weeks of gestation (when even the placenta has not yet formed) will also “get” to her child. The exact effects of many medications on the formation and development of the baby have not been studied. As for the drug Nise, studies on the safety of nimesulide (only this compound enters the bloodstream, albeit slightly, when applied topically) have not been conducted. The ban is based on the fact that the substance belongs to the group of sulfonamides (category B) - tests on animals did not reveal a negative reaction, but there are no studies on the use of the product in humans. In order to exclude the possibility of the formation of malformations (although nimesulide is not a mutagenic substance), the use of the gel in the early weeks of gestation is prohibited.
Nise gel during pregnancy - 2nd trimester
With the transition to the second trimester of gestation, the list of approved medications expands. This trend is associated with the completion of the formation of the placenta - a “child’s place” that filters many harmful compounds. As for Nise gel, the ban on its use also applies during this period. The limitations are due to the fact that nimesulide easily penetrates the placenta. In exceptional cases, in the presence of acute pain, the drug can only be applied once as prescribed by a doctor. The second trimester is the most loyal to this drug.
Nise gel during pregnancy - 3rd trimester
As the date of birth of the baby approaches, the severity of the ban on the use of Nise gel increases again. Even external use of the product can lead to such negative consequences as:
- A marked decrease in the tone of the uterine muscles, as well as their ability to contract (atony). This condition is especially dangerous during childbirth, because it threatens the woman with severe bleeding with a large amount of blood loss. Bleeding can be internal (hidden), which poses a serious threat to the life of the pregnant woman.
- Early closure (overgrowth) of the Botallian duct in a toddler. This arterial bed is a small duct connecting the pulmonary artery with the aorta. It is he who allows the baby to breathe in the mother's womb. Normally, this channel becomes overgrown after childbirth, when the child begins to breathe on his own. Premature closure of this channel threatens heart problems and impaired blood supply to the lungs.
Although statistics have confirmed such a negative effect only as a result of oral administration of the medicine and in large dosages, it is not worth the risk. Based on the severity of the negative reactions that are possible as a result of using Nise gel, a woman needs to choose a safer drug.
Summing up the results regarding Nise gel and its use during gestation, we repeat that the use of the medicine is prohibited. However, you should not panic unnecessarily if there was a single application of the drug. Most likely, the drug will not have a negative effect on either the course of pregnancy or the health of the baby in the womb. However, a woman must definitely consult a doctor, describe the pain that is bothering her and, together with the doctor, choose a safe therapy.