Composition, form of production and packaging
Suppositories rectal white or white with a creamy shade of color, torpedo-shaped.
1 supp.
diclofenac sodium 50 mg
Excipients: fat solid (Witepsol - H15, W35, Supposir - NA15, NAS35) - a sufficient amount until a suppository with a mass of 1.26 g.
5 pieces. - packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
NSAIDs. Has a pronounced anti-inflammatory, analgesic, antipyretic and antiplatelet effect, the mechanism of which is due to inhibition of the activity of COX-1 and COX-2, which leads to disruption of the metabolism of arachidonic acid and inhibition of the synthesis of prostaglandins in the inflammatory focus. In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac significantly reduces the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joints. Promotes an increase in the volume of movements in the affected joints.
With traumatic and postoperative pain, the drug reduces the pain syndrome, as well as the severity of inflammatory reactions.
At primary algodismenore weakens a painful syndrome and reduces a bleeding.
PHARMACOKINETICS
After rectal administration, C max is reached after 30 minutes.
In patients with chronic hepatitis or compensated cirrhosis, the pharmacokinetic parameters of diclofenac do not change.
INDICATIONS
- inflammatory and degenerative diseases of the joints (including rheumatoid arthritis, ankylosing spondylitis, juvenile arthritis, psoriatic arthritis, acute and chronic gouty arthritis);
- rheumatic affections of soft tissues;
- Post-traumatic pain syndrome (including traumatic bruises, sprains, muscles and tendons);
- soreness of muscles and joints, caused by heavy physical exertion;
- Lumbago;
- sciatica;
- neuralgia;
- Postoperative pain;
- Primary algodismenorea, adnexitis;
- migraine attacks;
- Renal and biliary colic;
- infectious and inflammatory diseases of ENT organs with severe pain syndrome (including pharyngitis, tonsillitis, otitis media);
- fever.
DOSING MODE
Adults appoint 1 soup. (50 mg) 2 times / day. The maximum daily dose is 150 mg (3 soups).
Migraine attacks: 100 mg (2 soups) at the first signs of an attack. If necessary, re-administer 100 mg (2 soups). If it is necessary to continue treatment in the following days, the daily dose should not exceed 150 mg (3 soups) per day.
Suppositories are injected into the rectum after spontaneous bowel cleansing or after a cleansing enema. After the introduction, the patient should be in the prone position for 20-30 minutes. The duration of the course of therapy is determined by the doctor individually, depending on the severity of the disease.
SIDE EFFECT
From the digestive system: gastralgia, nausea, vomiting, diarrhea, stomach pain, indigestion, constipation, flatulence, anorexia, increased activity of hepatic transaminases, bleeding from the digestive tract, hepatitis (including jaundice), fulminant hepatitis, pancreatitis, nonspecific colitis with bleeding, exacerbation of ulcerative colitis or Crohn's disease.
From the central nervous system and peripheral nervous system: headache, dizziness, fatigue, impaired perception, paresthesia, memory loss, loss of orientation, reduced visual acuity, diplopia, hearing loss, tinnitus, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremors, psychotic reactions, a violation of taste sensations.
From the urinary system: acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
From the hemopoietic system: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia.
Dermatological reactions: rashes, bullous eruptions, eczema, erythema multiforme, exfoliative dermatitis, alopecia, purpura.
Allergic reactions: bronchospasm, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), allergic purpura, photosensitization, systemic anaphylactic reactions (including shock).
Other: swelling, impotence, chest pain, palpitations, increased blood pressure.
Local reactions: irritation of the mucous membrane of the large intestine, mucous discharge with an admixture of blood, pain during defecation.
The resulting side effects depend on individual sensitivity, the magnitude of the dose used and the duration of treatment.
CONTRAINDICATIONS
- erosive and ulcerative lesions of the gastrointestinal tract in the phase of exacerbation;
- bleeding from the gastrointestinal tract, rectal bleeding;
- violation of hematopoiesis of unknown origin;
- Hemorrhoids, proctitis;
- "aspirin triad";
- Pregnancy;
- children's age till 6 years;
- Hypersensitivity to diclofenac sodium, acetylsalicylic acid and other NSAIDs.
With caution appoint with induced acute hepatic porphyria, impaired renal and hepatic function, heart failure, during lactation (breastfeeding).
PREGNANCY AND LACTATION
Diklovit is contraindicated in pregnancy.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution is prescribed for impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution appoint with induced acute hepatic porphyria, impaired liver function.
SPECIAL INSTRUCTIONS
If side effects occur, discontinue use.
OVERDOSE
Symptoms: dizziness, headache, hyperventilation, clouding of consciousness; in children - myoclonic cramps, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.
Treatment: prescribe activated charcoal, if necessary, perform symptomatic therapy.
DRUG INTERACTION
When used simultaneously with the drug Diklovit, the concentrations of digoxin, phenytoin, or lithium preparations in the blood plasma can increase.
When combined, Diqlovit reduces the effect of diuretics and antihypertensive agents.
With the simultaneous use of Diqlovit and potassium-sparing diuretics, hyperkalemia can occur.
When combined with NSAIDs and GCS, the risk of GI adverse reactions increases.
With simultaneous use with acetylsalicylic acid, a decrease in the concentration of diclofenac in the blood serum is possible.
When combined with Diqlovitis, the risk of nephrotoxic action of cyclosporine increases.
With the joint use of antidiabetics with Diqlovitis, the risk of hypo- or hyperglycemia is increased (if necessary, the combination of glucose in the blood should be monitored).
When methotrexate is used for 24 hours before or after the application of Diqlovit, an increase in the concentration of methotrexate in the blood plasma and an increase in its toxic effects are possible.
When combined with anticoagulants, monitoring of blood coagulability is necessary.
Decreases the effectiveness of hypnotics.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 20 В° C. Shelf life - 2 years.
