Alenthal pills, 100 mg, 20 pcs.

Composition

of 1 tab. :

– aceclofenac 100 mg

Pharmacological action

Pharmacological action-anti-inflammatory, antipyretic, analgesic.

Pharmacodynamics

Aceclofenac has anti-inflammatory, analgesic and antipyretic effects. Inhibits synthesis PG and thus affects the pathogenesis of inflammation, pain and fever. In rheumatic diseases, the anti-inflammatory and analgesic effect of aceclofenac significantly reduces the severity of pain, morning stiffness, and joint swelling, which improves the patient’s functional state.

Pharmacokinetics

Suction. After oral administration, aceclofenac is rapidly absorbed, its bioavailability is close to 100%. Tmax in blood plasma is 1.25-3 hours after oral administration. Food intake slows down absorption, but does not affect its degree.

Distribution. Aceclofenac is highly bound to plasma proteins (>99.7%). Aceclofenac penetrates the synovial fluid, where its concentration reaches 60% of its concentration in blood plasma. Vd is 30 liters.

Metabolism. It is believed that aceclofenac is metabolized by the CYP2C9 isoenzyme to form the 4-OH-aceclofenac metabolite, whose contribution to the clinical effect of the drug is most likely minimal. Diclofenac and 4-OH-aceclofenac are among the numerous metabolites of aceclofenac.

Output. The average T1 / 2 is 4-4.3 h. The clearance is 5 l/h. Approximately 2/3 of the dose taken is excreted by the kidneys, mainly in the form of conjugated hydroxymetabolites. Only 1% of the dose after oral administration is excreted unchanged.

Indications

relief of inflammation and pain in lumbago, toothache, scapular periarthritis, rheumatic soft tissue damage;

symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.

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

-hypocalcemia; – inability of the patient to stand or sit upright for at least 30 minutes; – severe renal failure (creatinine clearance less than 35 ml / min);— severe disorders of mineral metabolism— – strictures or achalasia of the esophagus and other conditions that lead to difficulty; – food movement through the esophagus;- severe hypoparathyroidism;— calcium malabsorption— – lactose intolerance— – lactase deficiency;— glucose-galactose malabsorption— – pregnancy; – lactation period— – childhood;- hypersensitivity. With caution, diseases of the gastrointestinal tract in the acute phase (dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer of the stomach and duodenum), vitamin D deficiency.

Side effects

From the digestive system: dysphagia, esophagitis, abdominal pain, heartburn, dyspepsia, constipation, diarrhea, flatulence. Rarely – nausea, vomiting, gastritis, melena, esophageal stricture, ulcers of the oral and pharyngeal mucosa, esophageal ulcer, perforation of the esophageal ulcer with bleeding.

From the musculoskeletal system: pain in the bones, muscles and joints.

From the central nervous system: headache

From the side of the organ of vision: uveitis, scleritis.

Allergic reactions: rarely-urticaria, angioedema; isolated cases of Stevens-Johnson and Lyell syndromes have been reported.

Others: rash, pruritus, erythema, photodermatosis, symptomatic hypocalcemia; cases of osteonecrosis of the upper and lower jaw are described, mainly in patients with cancer on the background of antitumor treatment, including bisphosphonates. Risk factors for osteonecrosis include cancer, chemotherapy, radiation therapy, corticosteroid therapy, poor oral hygiene, and local infectious and inflammatory processes, including osteomyelitis.

In most of the described cases, patients underwent tooth extraction during treatment with bisphosphonates.

Laboratory data: slight and transient decrease in calcium and phosphate concentrations.

Typical symptoms at the beginning of treatment are myalgia, malaise, and rarely fever.

Interaction

The interval between taking Alental and other medications and dietary supplements should be at least 1 hour. Combined use of alendronic acid (but not simultaneous use) with HRT drugs (estrogen+Aprogestin) is not accompanied by a change in the safety profile and tolerability of each drug compared to their separate use. The use of alendronic acid and HRT drugs (estrogen + progestin) leads to a greater increase in bone mass compared to taking each of the drugs separately.

Concomitant use of calcium supplements and antacids reduces the absorption of alendronic acid.

Ranitidine increases bioavailability by 2 times (clinical significance not determined). In clinical studies, there was an increase in the frequency of side effects from the upper gastrointestinal tract in patients who took more than 10 mg of alendronate per day simultaneously with drugs containing acetylsalicylic acid.

Sodium alendronate may be prescribed to patients taking NSAIDs. In a 3-year controlled clinical trial (number of 2027 patients), during which the majority of patients received NSAIDs as concomitant therapy, the number of adverse events related to the upper gastrointestinal tract was similar in patients receiving sodium alendronate at doses of 5 and 10 mg / day, and in patients receiving placebo.

However, the use of NSAIDs is associated with irritation of the gastrointestinal mucosa, so the use of NSAIDs together with alendronic acid should be cautious.

How to take, course of administration and dosage

Inside. For osteoporosis in postmenopausal women and men-70 mg once a week or 10 mg once a day, without chewing,2 hours (but not less than 30 minutes) before the first meal, water or other medications. Drink only plain water, as other beverages (including mineral water, coffee, tea, orange juice) reduce absorption. Tablets should not be chewed or dissolved.

For Paget’s disease – 40 mg/day. within 6 months.

No dose adjustment is required in elderly patients.

To reduce the irritating effect on the esophagus, Alental should be taken immediately after getting up in the morning, washed down with a full glass of water, after taking it, do not go to bed for 30 minutes (it is dangerous to use if the patient is unable to stand or sit up straight for 30 minutes).

Taking it at bedtime or in a horizontal position increases the risk of developing esophagitis.

If you accidentally miss taking the drug in a dosage once a week, you should take 1 tablet in the morning of the next day. You should not take the tablets in one day, but in the future you should continue to take 1 tablet on the day of the week that was chosen for taking from the very beginning of treatment.

No dose adjustment is required in patients with mild to moderate renal insufficiency (creatinine clearance from 35 to 60 ml / min).

Overdose

Symptoms:

hypocalcemia, hypophosphatemia, side effects from the upper gastrointestinal tract (heartburn, esophagitis, gastritis, ulcers).

Treatment:

there is no specific treatment. It is recommended to take milk, antacids. To avoid irritation of the esophagus, do not induce vomiting, the patient should be given an upright position (standing or sitting).

Special instructions

It is necessary to monitor the possibility of any signs of adverse reactions from the esophagus. The patient should be informed about the need to stop taking Alental and consult a doctor if dysphagia, pain when swallowing, pain behind the sternum or heartburn develops.

It is necessary to inform the patient about the possible risk. damage to the esophageal mucosa if the instructions for use are not followed.

In the presence of hypocalcemia, it is necessary to correct it before starting treatment. Therapy should be combined with a diet enriched with calcium salts and vitamin D.

During treatment, there may be a slight asymptomatic decrease in serum calcium and phosphate concentrations due to the positive effect of alendronic acid on bone mineral density, which is of particular importance for patients receiving corticosteroids, since they may have reduced calcium absorption.

Abnormal (i. e., low-force and spontaneous) subtrochanteric fractures or fractures of the proximal femoral diaphysis have been reported in a small number of patients treated with bisphosphonates. Some of the fractures were classified as stress fractures (also known as load fractures, marching fractures, Deutschlander fractures) that occur in the absence of injury.

Some patients experienced prodromal pain in the affected area weeks or months before the occurrence of a complete fracture, often associated with a characteristic radiographic picture of the stress fracture. The number of reports was very small, in addition, stress fractures with similar clinical features occur in patients who do not take bisphosphonates.

Patients with stress fractures should be evaluated for known causes and risk factors (e. g. vitamin D deficiency, malabsorption disorders, corticosteroid use, a history of stress fracture, arthritis or lower limb fracture, excessive or increased exercise, diabetes mellitus, chronic alcoholism) and provided with appropriate orthopedic care.Prior to receiving the results of the examination, consideration should be given to suspending bisphosphonates in patients with stress fractures, based on the assessment of the benefit/risk ratio in each case.

The ability to drive motor vehicles and manage mechanisms is not affected.

Form of production

Pills: round biconvex, covered with a film shell of white or almost white color.

On a cross-section — the core is white or almost white in color.

Active ingredient

Aceclofenac

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults, For adults as prescribed by a doctor, For athletes

Indications

Arthritis, Bruises, Osteoarthritis, Rheumatoid Arthritis, Osteoarthritis, Swelling after injuries and operations, Lumbago, Sciatica, Periarthritis, Sciatica

Weight

Weight: 20 g.