Description of the drug VOLTAREN® for systemic use
The dose is selected individually; it is recommended to use the drug in the minimum effective dose, with the shortest possible treatment period.
For oral and rectal use
Adults
When taken orally in the form of tablets of regular duration or rectally in the form of suppositories, the recommended initial dose is 100-150 mg/day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg/day is sufficient. The daily dose should be divided into several doses.
When taken in the form of extended-release tablets, the recommended initial dose is 100 mg 1 time / day. The same daily dose is used for moderately severe symptoms, as well as for long-term therapy. In cases where the symptoms of the disease are most pronounced at night or in the morning, it is advisable to take extended-release tablets at night.
To relieve night pain or morning stiffness
in addition to taking the drug during the day, diclofenac is prescribed in the form of rectal suppositories before bedtime; in this case, the total daily dose should not exceed 150 mg.
With primary dysmenorrhea
the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, over several menstrual cycles it can be increased to 150 mg/day. The drug should be started when the first symptoms appear. Depending on the dynamics of clinical symptoms, treatment can be continued for several days.
In elderly patients (65 years and older)
no adjustment of the initial dose is required.
In weakened patients, patients with low body weight
It is recommended to adhere to the minimum dose.
The drug should be used with particular caution in patients with diseases of the cardiovascular system (including uncontrolled arterial hypertension) or a high risk of developing cardiovascular diseases
. If long-term therapy (more than 4 weeks) is necessary in such patients, the drug should be used in a daily dose not exceeding 100 mg.
Children aged 1 year and older
The drug is prescribed in a dose of 0.5-2 mg/kg body weight/day (in 2-3 doses, depending on the severity of the disease). For the treatment of rheumatoid arthritis
the daily dose can be maximally increased to 3 mg/kg (in several doses). The maximum daily dose is 150 mg.
The drug in the form of extended-release tablets should not be used in children and adolescents under the age of 18 years.
For parenteral use
Adults
Injected deep into the / m. Single dose - 75 mg. If necessary, repeated administration is possible, but not earlier than after 12 hours.
Duration of use is no more than 2 days, if necessary, then switch to oral or rectal use of diclofenac.
In severe cases (for example, with colic), as an exception, 2 injections of 75 mg each can be given, with an interval of several hours (the second injection should be carried out in the opposite gluteal region). Alternatively, IM administration once a day (75 mg) can be combined with diclofenac in other dosage forms (tablets, rectal suppositories), and the total daily dose should not exceed 150 mg.
For migraine attacks
Diclofenac is recommended to be administered as early as possible after the onset of an attack, IM at a dose of 75 mg, followed by the use of suppositories at a dose of up to 100 mg on the same day, if required. The total daily dose should not exceed 175 mg on the first day.
In elderly patients (65 years and older)
no adjustment of the initial dose is required. In weakened patients and patients with low body weight, it is recommended to adhere to the minimum dose.
The drug should be used with particular caution in patients with diseases of the cardiovascular system (including uncontrolled arterial hypertension) or a high risk of developing cardiovascular diseases
. If long-term therapy (more than 4 weeks) is necessary in such patients, the drug should be used in a daily dose not exceeding 100 mg.
Children and teenagers under 18 years of age
Diclofenac should not be used intramuscularly in children and adolescents under 18 years of age due to the difficulty of dosing the drug.
Voltaren solution for intramuscular administration 25 mg/ml ampoule 3 ml N5
Registration Certificate Holder
NOVARTIS PHARMA (Switzerland)
Dosage form
Medicine - Voltaren®
Description
Solution for intramuscular administration
from colorless to light yellow.
1 ml
1 amp.
diclofenac sodium 25 mg 75 mg
Excipients
: mannitol - 18 mg, propylene glycol - 600 mg, benzyl alcohol - 120 mg, sodium disulfite - 2 mg, sodium hydroxide - up to pH 7.8-8.0, liquid water - up to 3 ml.
3 ml - colorless glass ampoules with a break point or break ring (5) - cardboard packs with an insert with cells for ampoules.
Indications
Inflammatory and degenerative diseases of the musculoskeletal system, incl. rheumatoid, juvenile, chronic arthritis; ankylosing spondylitis and other spondyloarthropathy; osteoarthritis; gouty arthritis; bursitis, tendovaginitis; pain syndrome from the spine (lumbago, sciatica, ossalgia, neuralgia, myalgia, arthralgia, radiculitis); post-traumatic postoperative pain syndrome accompanied by inflammation (for example, in dentistry and orthopedics); algodismenorrhea; inflammatory processes in the pelvis (including adnexitis); infectious and inflammatory diseases of the ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media.
Isolated fever is not an indication for the use of the drug.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.
Contraindications for use
Hypersensitivity to diclofenac and excipients of the drug used; “aspirin triad” (attacks of bronchial asthma, urticaria and acute rhinitis when taking acetylsalicylic acid or other NSAIDs); erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; proctitis (only for suppositories); pregnancy (for intramuscular administration); III trimester of pregnancy (for oral and rectal administration); children and adolescents up to 18 years of age (for intramuscular administration and for long-acting dosage forms).
Carefully :
suspicion of gastrointestinal disease; indications in the anamnesis of bleeding from the gastrointestinal tract and perforation of the ulcer (especially in elderly patients), Helicobacter pylori infections, ulcerative colitis, Crohn's disease, dysfunction; mild to moderate liver dysfunction, hepatic porphyria (diclofenac can provoke attacks of porphyria); in patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (including polyps in the nasal cavity), COPD, chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis-like symptoms); cardiovascular diseases (including coronary artery disease, cerebrovascular diseases, compensated heart failure, peripheral vascular diseases); impaired renal function, including chronic renal failure (creatinine clearance 30-60 ml/min); dyslipidemia/hyperlipilemia; diabetes; arterial hypertension; a significant decrease in blood volume of any etiology (for example, in the periods before and after major surgical interventions); violation of the hemostasis system; risk of developing thrombosis (including myocardial infarction and stroke); elderly patients, especially those who are weakened or have low body weight (diclofenac should be used in the minimum effective dose); in patients receiving drugs that increase the risk of gastrointestinal bleeding, including systemic corticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel, acetylsalicylic acid), selective inhibitors serotonin reuptake (including citalopram, fluoxetine, paroxetine, sertraline); simultaneous treatment with diuretics or other drugs that can impair renal function; when treating smoking patients or patients who abuse alcohol; when administered intramuscularly to patients with bronchial asthma due to the risk of exacerbation of the disease (since sodium bisulfite, which is contained in some dosage forms for injection, can cause severe hypersensitivity reactions).
pharmachologic effect
NSAID, phenylacetic acid derivative. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play an important role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).
In vitro, at concentrations equivalent to those achieved when treating patients, it does not inhibit the biosynthesis of cartilage tissue proteoglycans.
For rheumatic diseases, it reduces pain in the joints at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase range of motion. Reduces post-traumatic and postoperative pain, as well as inflammatory swelling.
In case of post-traumatic and postoperative inflammatory phenomena, it quickly relieves pain (arising both at rest and during movement), reduces inflammatory swelling and swelling of the postoperative wound.
Suppresses platelet aggregation. With long-term use it has a desensitizing effect.
Drug interactions
Potent CYP2C9 inhibitors -
When diclofenac is co-administered with strong CYP2C9 inhibitors (such as voriconazole), it is possible to increase the concentration of diclofenac in the blood serum and enhance the systemic effect caused by inhibition of the metabolism of diclofenac.
Lithium, digoxin -
it is possible to increase the concentration of lithium and digoxin in plasma. It is recommended to monitor the concentration of lithium and digoxin in the blood serum.
Diuretics and antihypertensive drugs -
when used simultaneously with diuretics and antihypertensive drugs (for example, beta-blockers, ACE inhibitors), diclofenac may reduce their hypotensive effect.
Cyclosporine -
the effect of diclofenac on the activity of prostate glandins in the kidneys may enhance the nephrotoxicity of cyclosporine.
Drugs that can cause hyperkalemia -
Concomitant use of diclofenac with potassium-sparing diuretics, cyclosporine, tacrolimus and trimethoprim may lead to an increase in plasma potassium levels (in the case of such a combination, this indicator should be monitored frequently).
Antibacterial agents quinolone derivatives -
There are isolated reports of the development of seizures in patients receiving quinolone derivatives and diclofecac simultaneously.
NSAIDs and GCS -
with simultaneous systemic use of diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of adverse events (in particular, from the gastrointestinal tract).
Anticoagulants and antiplatelet agents
— an increased risk of bleeding cannot be excluded when diclofenac is used simultaneously with drugs from these groups.
Selective serotonin reuptake inhibitors
- there may be an increased risk of gastrointestinal bleeding.
Hypoglycemic drugs -
Cases of both hypoglycemia and hyperglycemia cannot be excluded, which necessitated the need to change the dose of hypoglycemic drugs during the use of diclofenac.
Methotrexate -
when diclofenac is used within 24 hours before or within 24 hours after taking methotrexate, the concentration of methotrexate in the blood may increase and its toxic effect may increase.
Phenytoin -
the effect of phenytoin may be enhanced.
Dosage regimen
The dose is selected individually; it is recommended to use the drug in the minimum effective dose, with the shortest possible treatment period.
For oral and rectal use
Adults
When taken orally in the form of tablets of regular duration or rectally in the form of suppositories, the recommended initial dose is 100-150 mg/day. In relatively mild cases of the disease, as well as for long-term therapy, 75-100 mg/day is sufficient. The daily dose should be divided into several doses.
When taken in the form of extended-release tablets, the recommended initial dose is 100 mg 1 time / day. The same daily dose is used for moderately severe symptoms, as well as for long-term therapy. In cases where the symptoms of the disease are most pronounced at night or in the morning, it is advisable to take extended-release tablets at night.
To relieve night pain or morning stiffness
in addition to taking the drug during the day, diclofenac is prescribed in the form of rectal suppositories before bedtime; in this case, the total daily dose should not exceed 150 mg.
With primary dysmenorrhea
the daily dose is selected individually; usually it is 50-150 mg. The initial dose should be 50-100 mg; if necessary, over several menstrual cycles it can be increased to 150 mg/day. The drug should be started when the first symptoms appear. Depending on the dynamics of clinical symptoms, treatment can be continued for several days.
In elderly patients (65 years and older)
no adjustment of the initial dose is required.
In weakened patients, patients with low body weight
It is recommended to adhere to the minimum dose.
The drug should be used with particular caution in patients with diseases of the cardiovascular system (including uncontrolled arterial hypertension) or a high risk of developing cardiovascular diseases
. If long-term therapy (more than 4 weeks) is necessary in such patients, the drug should be used in a daily dose not exceeding 100 mg.
Children aged 1 year and older
The drug is prescribed in a dose of 0.5-2 mg/kg body weight/day (in 2-3 doses, depending on the severity of the disease). For the treatment of rheumatoid arthritis
the daily dose can be maximally increased to 3 mg/kg (in several doses). The maximum daily dose is 150 mg.
The drug in the form of extended-release tablets should not be used in children and adolescents under the age of 18 years.
For parenteral use
Adults
Injected deep into the / m. Single dose - 75 mg. If necessary, repeated administration is possible, but not earlier than after 12 hours.
Duration of use is no more than 2 days, if necessary, then switch to oral or rectal use of diclofenac.
In severe cases (for example, with colic), as an exception, 2 injections of 75 mg each can be given, with an interval of several hours (the second injection should be carried out in the opposite gluteal region). Alternatively, IM administration once a day (75 mg) can be combined with diclofenac in other dosage forms (tablets, rectal suppositories), and the total daily dose should not exceed 150 mg.
For migraine attacks
Diclofenac is recommended to be administered as early as possible after the onset of an attack, IM at a dose of 75 mg, followed by the use of suppositories at a dose of up to 100 mg on the same day, if required. The total daily dose should not exceed 175 mg on the first day.
In elderly patients (65 years and older)
no adjustment of the initial dose is required. In weakened patients and patients with low body weight, it is recommended to adhere to the minimum dose.
The drug should be used with particular caution in patients with diseases of the cardiovascular system (including uncontrolled arterial hypertension) or a high risk of developing cardiovascular diseases
.
If long-term therapy (more than 4 weeks) is necessary in such patients, the drug should be used in a daily dose not exceeding 100 mg. Children and adolescents under 18 years of age
Diclofenac should not be used intramuscularly in children and adolescents under 18 years of age due to the difficulty of dosing the drug.
Side effect
Determination of the frequency of adverse reactions: very often (≥1/10), often (≥1/100, <1/10) infrequently (≥1/1000, <1/100), rarely (≥1/10,000, <1/ 1000), very rare (<1/10,000).
From the digestive system:
often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, decreased appetite, anorexia, increased aminotransferase activity in the blood serum; rarely - gastritis, gastrointestinal bleeding, vomiting blood, melena, diarrhea mixed with blood, stomach and intestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, liver dysfunction; very rarely - stomatitis, glossitis, damage to the esophagus, the occurrence of diaphragm-like strictures in the intestine, colitis (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn's disease), constipation, pancreatitis, fulminant hepatitis, liver necrosis, liver failure.
From the nervous system:
often - headache, dizziness; rarely - drowsiness; very rarely - sensory disturbances, including paresthesia, memory disorders, tremors, convulsions, anxiety, acute cerebrovascular accidents, aseptic meningitis; very rarely - disorientation, depression, insomnia, nightmares, irritability, mental disorders.
From the senses:
often - vertigo; very rarely - visual impairment (blurred vision), diplopia, hearing impairment, tinnitus, dysgeusia.
Dermatological reactions:
often - skin rash; rarely - urticaria; very rarely - bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), exfoliative dermatitis, itching, hair loss, photosensitivity reactions; purpura, Henoch-Schönlein purpura.
From the genitourinary system:
very rarely - acute renal failure, hematuria, proteinuria, tubulointerstitial nephritis, nephrotic syndrome, papillary necrosis.
From
the hematopoietic system:
very rarely - thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, agranulocytosis.
Allergic reactions:
rarely - hypersensitivity, anaphylactic/anaphylactoid reactions, including decreased blood pressure and shock; very rarely - angioedema (including facial swelling).
From the cardiovascular system:
very rarely - palpitations, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.
There is evidence of a slight increase in the risk of developing cardiovascular thrombotic complications (for example, myocardial infarction), especially with long-term use of diclofenac in high doses (daily dose more than 150 mg). From the respiratory system:
rarely - asthma (including shortness of breath); very rarely - pneumonitis.
General reactions:
rarely - swelling.
special instructions
Use with extreme caution in patients with a history of liver, kidney, gastrointestinal diseases, dyspeptic symptoms, bronchial asthma, arterial hypertension, heart failure, immediately after major surgical interventions, as well as in elderly patients.
If there is a history of allergic reactions to NSAIDs and sulfites, diclofenac is used only in emergency cases. During treatment, systematic monitoring of liver and kidney function and peripheral blood patterns is necessary.
Rectal use is not recommended in patients with diseases of the anorectal region or a history of anorectal bleeding. It should be used externally only on undamaged areas of the skin.
Avoid contact of diclofenac with the eyes (except for eye drops) or mucous membranes. Patients using contact lenses should use eye drops no earlier than 5 minutes after removing the lenses.
Not recommended for use in children under 6 years of age.
During treatment with dosage forms for systemic use, alcohol consumption is not recommended.
Effect on the ability to drive vehicles and machinery
During the treatment period, the speed of psychomotor reactions may decrease. If your vision becomes blurred after using eye drops, you should not drive a car or engage in other potentially hazardous activities.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.
There is insufficient data on the safety of diclofenac in pregnant women. Therefore, administration in the first and second trimesters of pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Diclofenac (like other inhibitors of prostaglandin synthesis) is contraindicated in the third trimester of pregnancy (possible suppression of uterine contractility and premature closure of the ductus arteriosus in the fetus).
Despite the fact that diclofenac is excreted in breast milk in small quantities, use during lactation (breastfeeding) is not recommended. If use is necessary during lactation, breastfeeding should be discontinued.
Since diclofenac (like other NSAIDs) may have a negative effect on fertility, use in women planning pregnancy is not recommended.
For patients undergoing examination and treatment for infertility, the drug should be discontinued.
Use for renal impairment
Restrictions for impaired renal function - With caution.
Use with extreme caution if you have a history of kidney disease.
Use for liver dysfunction
Restrictions for liver dysfunction - With caution.
Use with extreme caution if you have a history of liver disease.
Use in elderly patients
Restrictions for elderly patients - Use with caution.
Use with extreme caution in elderly patients.
Use in children
Restrictions for children - Contraindicated.
Not recommended for use in children under 6 years of age.
