REGISTRATION NUMBER
R N001939/02-071008 [Р N001939/02-071008]
TRADE NAME
Hypoxen®
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Sodium polydihydroxyphenylenethiosulfonate
DOSAGE FORM
Capsules
COMPOSITION
Active ingredient: sodium polydihydroxyphenylenethiosulfonate (Hypoxen®) 250 mg
Capsule materials: gelatin, black iron oxide (E 172), red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171)
DESCRIPTION
Hard gelatin capsules No.3, dark brown in color. The manufacturer’s logo is printed on the capsule in white (titanium dioxide). The capsule contents are black powder with no odor or with a slight specific odor.
PHARMACOLOGICAL GROUP
Antihypoxant agent
ATC CODE
[N07 XX]
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Hypoxen belongs to the class of antihypoxants and antioxidants that reduce oxygen consumption and increase body performance in extreme situations. The drug exhibits antihypoxic action by increasing the efficiency of tissue respiration under hypoxic conditions, especially in organs with high metabolic rates (brain, cardiac muscle, liver).
Hypoxen provides: reduced oxygen consumption during significant physical exertion, improved tissue respiration, decreased mental and physical fatigue, successful performance of labor-intensive physical operations.
INDICATIONS
- For increasing performance in extreme and adverse conditions associated with oxygen deficiency (high altitude, polar conditions, underwater work, etc.)
- Mental and physical overexertion, operator activities and other intensive loads accompanied by chronic fatigue
- As part of complex therapy for severe traumatic injuries, blood loss, extensive surgical interventions, respiratory diseases (bronchial asthma, pneumonia, obstructive bronchitis)
- As part of complex therapy for stable angina (prevention of angina attacks), arterial hypertension, chronic heart failure NYHA class I and II
CONTRAINDICATIONS
Individual intolerance, pregnancy, lactation period, hemorrhagic stroke.
DOSAGE AND ADMINISTRATION
Take orally in adults, before or during meals, with a small amount of water. Single dose for adults is 2-4 capsules. Maximum daily dose is 12 capsules.
Daily dose calculation based on body weight:
| Body weight (kg) | Daily dose (capsules) |
|---|---|
| 60-70 | 3-4 |
| 70-80 | 4-6 |
| 80-90 | 6-8 |
| 90-100 | 8-10 |
| 100-120 | 10-12 |
Specific dosing regimens:
- For hypoxia in extreme conditions (pulmonary hypoventilation, high altitude, underwater work, high-temperature conditions, sports): 1 daily dose 30-60 minutes before exertion
- For prolonged mental activity, chronic fatigue, reduction of recovery period after excessive physical exertion, trauma, surgery: ½ daily dose twice daily for 2-3 weeks. Courses can be repeated with 1-2 week intervals
- Complex treatment of pneumonia: ½ daily dose twice daily, 14-day course
- Complex treatment of obstructive bronchitis: ½ daily dose twice daily – 2 courses of 14 days with 7-day interval
- Complex treatment of bronchial asthma: ½ daily dose twice daily; 21-30 day courses with 10-day intervals
- Complex prevention of stable angina: ½ daily dose twice daily, 15-30 day course with 10-day interval
- Complex treatment of hypertension: ½ daily dose twice daily, 10-day course
- Complex treatment of heart failure: ½ daily dose twice daily, 10-14 day course
SIDE EFFECTS
Individual drug intolerance, allergic reactions.
OVERDOSE
Symptoms: dry mouth, nausea and abdominal discomfort, in rare cases – respiratory depression.
Treatment: gastric lavage, activated charcoal administration, symptomatic therapy.
DRUG INTERACTIONS
No negative pharmaceutical, pharmacodynamic, or pharmacokinetic interactions with other medications have been established. No incompatibilities with other medications have been identified.
FORM OF RELEASE
250 mg capsules. 30 capsules in polymer bottles or polymer vials. Bottle or vial with instructions in a cardboard box or chrome-ersatz package. 10 capsules in blister pack. 2 or 3 blister packs with instructions in a cardboard box or chrome-ersatz package.
STORAGE CONDITIONS
Store in a light-protected place at temperature not exceeding 25°C. Keep out of reach of children.
SHELF LIFE
4 years. Do not use after expiration date.
DISPENSING CONDITIONS
Over-the-counter
MANUFACTURER
Valenta Pharm / Olifen Pharmaceutical Factory, Russia. https://www.valentapharm.com/eng/, https://www.olifen-corp.ru/