Diclofenac gel for external use 1% 100g
Active substance
Diclofenac
pharmachologic effect
NSAID for external use, a derivative of phenylacetic acid. Has anti-inflammatory and analgesic effects. The mechanism of action is due to inhibition of the activity of COX-1 and COX-2, which leads to disruption of the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.
When used externally, it leads to the disappearance or weakening of pain at the site of application, reduces pain in the joints at rest and during movement, as well as morning stiffness and swelling of the joints. Helps increase range of motion in affected joints.
Indications of the active substances of the drug Diclofenac
Back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica); pain in the joints (including finger joints, knees) due to rheumatoid arthritis, osteoarthritis; muscle pain (due to sprains, strains, bruises, injuries); inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues).
Dosage regimen
When used externally, the amount of the drug depends on the size of the painful area. The single dose depends on the dosage form used and the age of the patient.
Gel, ointment, spray for external use
For adults and children over 12 years of age, the drug should be applied to the skin over the area of inflammation 3-4 times a day, for children aged 6 to 12 years - up to 2 times a day.
The duration of use depends on the indications and effectiveness of treatment. After 2 weeks of using the drug, the patient should consult a doctor.
Transdermal patch
Used as applications to the skin.
For adults, elderly patients and adolescents over 15 years of age, the patch is applied to the skin over the painful area for 24 hours. Only 1 patch is allowed to be used per day.
When treating soft tissue injuries, the patch is used for no more than 14 days, and when treating diseases of muscles and joints - no more than 21 days, unless there are special recommendations from a doctor.
If there is no improvement after 7 days and if your health worsens, you should consult a doctor.
Before use, consultation with a specialist is required.
The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor.
Storage mode, interactions and side effects are indicated in the instructions.
Contraindications for use
“Aspirin triad” (attacks of bronchial asthma, urticaria and acute rhinitis when taking acetylsalicylic acid or other NSAIDs); violation of the integrity of the skin at the site of application of the drug; III trimester of pregnancy; lactation period (breastfeeding); children up to 6 years of age and older, depending on the drug used; hypersensitivity to diclofenac, other NSAIDs or to any of the excipients of the drug used.
With caution: hepatic porphyria (in the acute phase); erosive and ulcerative lesions of the gastrointestinal tract; severe dysfunction of the liver and kidneys; chronic heart failure; bronchial asthma; bleeding disorders (including hemophilia, prolongation of bleeding time, bleeding tendency); I and II trimesters of pregnancy; elderly patients.
Use during pregnancy and breastfeeding
Use is contraindicated in the third trimester of pregnancy due to the possibility of decreased uterine tone and/or premature closure of the fetal ductus arteriosus.
Use in the first and second trimesters of pregnancy is possible in cases where the potential benefit to the mother outweighs the potential risk to the fetus or infant.
Use during lactation (breastfeeding) is contraindicated.
Diclofenac Forte gel for external use 50mg/1g 40g No.1
Name
Diclofenac Forte gel 50mgg 40g Pharmtechnology
Description
Colorless or slightly yellowish, transparent or almost transparent gel, uniform in consistency. Air bubbles are allowed.
Main active ingredient
Diclofenac
Release form
gel
Dosage
40g
Indications for use
For local symptomatic treatment of pain and inflammation in: Traumatic injury to tendons, ligaments, muscles and joints (for example, as a result of dislocation, sprain or bruise). Localized forms of rheumatic diseases with damage to soft tissues.
Directions for use and doses
Adults and children over 14 years of age: a small amount of gel 2-4 g (gel strip 1-2 cm) is applied 2-3 times a day in a thin layer to the skin above the inflammation and lightly rubbed until completely absorbed. After applying the gel, you must wash your hands thoroughly, except in cases where the drug must be applied directly to your hands. The interval between application of the drug should be at least 4 hours. If symptoms persist for more than 7 days or the condition worsens, you should consult your doctor. Do not use for more than 7 days unless otherwise recommended by a doctor. Elderly: The usual dose may be used. Children and adolescents: There is insufficient data on effectiveness and safety for children and adolescents under 14 years of age (see Contraindications section). When using the drug in children 14 years of age and older for more than 7 days, as well as if the condition worsens, parents should consult a doctor.
Use during pregnancy and lactation
Use during pregnancy Plasma concentrations of diclofenac after topical administration are lower than after oral administration. Taking into account the information obtained from the systemic use of NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the course of pregnancy and/or the embryo/fetus. Data from epidemiological studies show an increased risk of miscarriage and the formation of heart defects and gastroschisis when using prostaglandin synthesis inhibitors in early pregnancy. The risk of heart disease increases from less than 1% to approximately 1.5%. An increase in risk presumably occurs with increasing dose and duration of treatment. In animal experiments, administration of a prostaglandin synthesis inhibitor leads to an increased risk of pre- and post-implantation miscarriage and fetal mortality. In addition, there is an increase in the incidence of various malformations, including the cardiovascular system, in animals treated with prostaglandin synthesis inhibitors during the period of organogenesis. The use of diclofenac is not recommended in the first and second trimester of pregnancy, except in cases where the benefits of the drug outweigh the risks of its use. If diclofenac is used during pregnancy planning, the first or second trimesters of pregnancy, the drug is prescribed in the lowest dose for the shortest period of time. The use of prostaglandin synthesis inhibitors in the third trimester of pregnancy can lead to the development of: heart defects (premature closure of the ductus arteriosus with the development of pulmonary hypertension); impaired renal function, up to the development of renal failure with oligohydroamnion; When using the drug at the end of pregnancy, the mother and/or newborn may experience effects: prolongation of bleeding time, antiplatelet effect, which can develop even when taking very low doses. decreased contractility of the uterus, which can cause delayed or prolonged labor. Therefore, diclofenac is contraindicated during the third trimester of pregnancy. Use during breastfeeding Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, no effect on a breastfed baby is expected when using Diclofenac Forte, gel in therapeutic doses. Due to the lack of controlled studies in women during breastfeeding, the drug should only be used under the supervision of a physician. Diclofenac Forte, gel should not be applied to the chest area, as well as to large areas of the skin and/or for a long period of time. Effect on the ability to drive and operate machinery When applied topically, Diclofenac Forte gel does not affect the ability to drive and operate machinery.
Interaction with other drugs
Interaction with other drugs is unlikely due to the low systemic absorption of diclofenac when applied topically. The interaction of Diclofenac Forte, gel with other drugs has not been registered, but when prescribing drugs simultaneously, it is necessary to take into account the information contained in the instructions for medical use for the oral form of diclofenac. Concomitant use of Diclofenac Forte, gel with aspirin or other NSAIDs may increase the risk of adverse reactions.
Contraindications
Patients with asthma attacks, urticaria or acute rhinitis that occur when using acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity to diclofenac, acetylsalicylic acid, NSAIDs or any of the excipients. Third trimester of pregnancy. Simultaneous oral administration with other NSAIDs. Diclofenac Forte, gel is contraindicated when used simultaneously with other drugs containing diclofenac. Use in children and adolescents under 14 years of age. Special instructions The medicine should be applied only to intact areas of the skin, avoiding contact with open wounds. Avoid getting the gel into the eyes and mucous membranes. When applying the drug to large areas of the skin and/or with prolonged use, the possibility of systemic side effects of diclofenac cannot be completely excluded. During therapy with this drug, the activity of liver enzymes may increase. If any side effects occur, you should stop using the gel and consult a doctor. You should consult your doctor before using the gel while taking other non-steroidal anti-inflammatory drugs. In isolated cases, gastrointestinal bleeding has been reported in patients with an active phase or a history of gastric or duodenal ulcers. Diclofenac, like other NSAIDs that inhibit prostaglandin synthetase activity, can provoke the development of bronchospasm in patients with a history of asthma or allergic diseases. It is necessary to stop using the drug if a skin rash occurs. Diclofenac Forte, gel contains propylene glycol, which may cause local skin irritation in some people. Diclofenac Forte, gel cannot be used under an occlusive dressing.
Compound
1 g of gel contains 50 mg of diclofenac diethylamine as an active ingredient (in terms of diclofenac sodium). Excipients: ethyl alcohol 96%, propylene glycol, carbomer, dimethyl sulfoxide, glycerin, macrogol 400, diethanolamine, purified water.
Overdose
Clinical picture Due to low systemic absorption, the development of an overdose with local use is unlikely. However, it is possible to develop undesirable effects similar to the effects of an overdose of oral forms of diclofenac if the gel is accidentally or intentionally ingested. If ingested, severe systemic side effects may develop, requiring the usual therapeutic measures in the treatment of NSAID poisoning, including gastric lavage and taking adsorbents (activated carbon) as soon as possible after ingestion. Treatment In case of overdose, pathogenetic and symptomatic therapy is used. There is no typical clinical picture of an overdose of diclofenac. Specific therapy (for example, forced diuresis, dialysis, hemoperfusion) is ineffective due to the high binding of NSAIDs to proteins and their intensive metabolism.
Side effect
Frequency of side effects: very often (? 1/10); often (?1/100 to
Storage conditions
Store at a temperature not exceeding 25°C. Keep out of the reach of children.