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Z pack mg dosage: Zithromax (azithromycin) dosing, indications, interactions, adverse effects, and more

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Zithromax Dosage Guide – Drugs.com

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Generic name: AZITHROMYCIN DIHYDRATE 250mg
Dosage forms: tablet, film coated, oral suspension
Drug class: Macrolides

Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.

Adult Patients

[see Indications and Usage (1.1) and Clinical Pharmacology (12.3)]

Infection*Recommended Dose/Duration of Therapy
*
DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.1)]
Community-acquired pneumonia Pharyngitis/tonsillitis (second-line therapy)
Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease500 mg once daily for 3 days
OR
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5
Acute bacterial sinusitis500 mg once daily for 3 days
Genital ulcer disease (chancroid)One single 1 gram dose
Non-gonococcal urethritis and cervicitisOne single 1 gram dose
Gonococcal urethritis and cervicitisOne single 2 gram dose

ZITHROMAX tablets can be taken with or without food.

Pediatric Patients1

Infection*Recommended Dose/Duration of Therapy
1 see dosing tables below for maximum doses evaluated by indication
*
DUE TO THE INDICATED ORGANISMS [see Indications and Usage (1.2)]
Acute otitis media30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis10 mg/kg once daily for 3 days.
Community-acquired pneumonia10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
Pharyngitis/tonsillitis12 mg/kg once daily for 5 days.

ZITHROMAX for oral suspension can be taken with or without food.

PEDIATRIC DOSAGE GUIDELINES FOR OTITIS MEDIA, ACUTE BACTERIAL SINUSITIS, AND COMMUNITY-ACQUIRED PNEUMONIA
(Age 6 months and above, [see Use in Specific Populations (8. 4)])
Based on Body Weight

OTITIS MEDIA AND COMMUNITY-ACQUIRED PNEUMONIA: (5-Day Regimen)*
Dosing Calculated on 10 mg/kg/day Day 1 and 5 mg/kg/day Days 2 to 5.
Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
KgDay 1Days 2–5Day 1Days 2–5
*
Effectiveness of the 3-day or 1-day regimen in pediatric patients with community-acquired pneumonia has not been established.
52.5 mL; (½ tsp)1.25 mL;(¼ tsp)7.5 mL150 mg
105 mL; (1tsp)2.5 mL; (½ tsp)15 mL300 mg
205 mL; (1 tsp)2. 5 mL; (½ tsp)15 mL600 mg
307.5 mL; (1½ tsp)3.75 mL; (¾ tsp)22.5 mL900 mg
4010 mL; (2 tsp)5 mL; (1 tsp)30 mL1200 mg
50 and above12.5 mL; (2½ tsp)6.25 mL; (1¼ tsp)37.5 mL1500 mg
OTITIS MEDIA AND ACUTE BACTERIAL SINUSITIS: (3-Day Regimen)*
Dosing Calculated on 10 mg/kg/day.
Weight100 mg/5 mL200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
KgDays 1–3Days 1–3
*
Effectiveness of the 5-day or 1-day regimen in pediatric patients with acute bacterial sinusitis has not been established.
52.5 mL; (1/2 tsp)7.5 mL150 mg
105 mL; (1 tsp)15 mL300 mg
205 mL (1 tsp)15 mL600 mg
307.5 mL (1½ tsp)22.5 mL900 mg
4010 mL (2 tsp)30 mL1200 mg
50 and above12.5 mL (2 ½ tsp)37.5 mL1500 mg
OTITIS MEDIA: (1-Day Regimen)
Dosing Calculated on 30 mg/kg as a single dose.
Weight200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
Kg1-Day Regimen
53.75 mL;(3/4 tsp)3.75 mL150 mg
107. 5 mL;(1½ tsp)7.5 mL300 mg
2015 mL;(3 tsp)15 mL600 mg
3022.5 mL;(4½ tsp)22.5 mL900 mg
4030 mL;(6 tsp)30 mL1200 mg
50 and above37.5 mL;(7½ tsp)37.5 mL1500 mg

The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

Pharyngitis/Tonsillitis: The recommended dose of ZITHROMAX for children with pharyngitis/tonsillitis is 12 mg/kg once daily for 5 days. (See chart below.)

PEDIATRIC DOSAGE GUIDELINES FOR PHARYNGITIS/TONSILLITIS
(Age 2 years and above, [see Use in Specific Populations (8. 4)])
Based on Body Weight

PHARYNGITIS/TONSILLITIS: (5-Day Regimen)
Dosing Calculated on 12 mg/kg/day for 5 days.
Weight200 mg/5 mLTotal mL per Treatment CourseTotal mg per Treatment Course
KgDay 1–5
82.5 mL; (½ tsp)12.5 mL500 mg
175 mL; (1 tsp)25 mL1000 mg
257.5 mL; (1½ tsp)37.5 mL1500 mg
3310 mL; (2 tsp)50 mL2000 mg
4012.5 mL; (2½ tsp)62.5 mL2500 mg

Constituting instructions for ZITHROMAX Oral Suspension 300, 600, 900, 1200 mg bottles. The table below indicates the volume of water to be used for constitution:

Amount of water to be addedTotal volume after constitution
(azithromycin content)
Azithromycin concentration after constitution
9 mL (300 mg)15 mL (300 mg)100 mg/5 mL
9 mL (600 mg)15 mL (600 mg)200 mg/5 mL
12 mL (900 mg)22. 5 mL (900 mg)200 mg/5 mL
15 mL (1200 mg)30 mL (1200 mg)200 mg/5 mL

Shake well before each use. Oversized bottle provides shake space. Keep tightly closed.

After mixing, store suspension at 5° to 30°C (41° to 86°F) and use within 10 days. Discard after full dosing is completed.

Frequently asked questions

  • What are the best antibiotics for a tooth infection?
  • What antibiotics kill Covid-19 (coronavirus)?
  • What are the best antibiotics for pneumonia?
  • How long does azithromycin stay in your system?
  • What is the best antibiotic to treat strep throat?
  • Does azithromycin cure chlamydia: How much / how long?
  • Can I drink alcohol while taking Zithromax?
  • Is Zithromax a penicillin?
  • How long does Zithromax stay in your system?
  • Is Zithromax available over the counter?
  • Can you take antibiotics with Mavyret?
  • What antibiotics are used to treat chlamydia and gonorrhea?
  • Can you drink alcohol with Z-Pak (Azithromycin)?
  • Was azithromycin in my system long enough to treat chlamydia after throwing up?
  • Zithromax Z-Pak – can Tums (antacids) be taken with Z-Pak?

More about Zithromax (azithromycin)

  • Check interactions
  • Compare alternatives
  • Pricing & coupons
  • Reviews (131)
  • Drug images
  • Latest FDA alerts (3)
  • Side effects
  • Patient tips
  • During pregnancy
  • Generic availability
  • Support group
  • Drug class: macrolides
  • Breastfeeding

Patient resources

  • Drug Information
  • Zithromax IV
  • Zithromax Z-Pak
  • Zithromax (Azithromycin Intravenous) (Advanced Reading)
  • Zithromax (Azithromycin Oral) (Advanced Reading)
Other brands

Azithromycin Dose Pack, Zmax

Professional resources

  • Prescribing Information

Related treatment guides

  • Bacterial Infection
  • Bacterial Endocarditis Prevention
  • Babesiosis
  • Bartonellosis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Azithromycin (Zithromax®) for Cats and Dogs

Content Sponsored by Chewy.

Overview of Azithromycin for Canines and Felines

  • Azithromycin, better known as Zithromax® or “Z-pack” in humans, is an antibacterial drug used in dogs and cats to treat a variety of conditions, including dermatological infections, respiratory tract infections, and urogenital infections.
  • Azithromycin, invented in 1980 and derived from erythromycin, belongs to the azalide subclass of macrolide antibiotics. Like other macrolide antibiotics, it works by binding to the “P” site of the 50S ribosomal subunit of susceptible microorganisms interrupting RNA-dependent protein synthesis.
  • Susceptible bacteria include Staphylococcus aureus, various Streptococci, some Hemophilus spp, certain Bacteroides spp, Borrelia burgdorferi, some Mycoplasma spp, and some species of Chlamydia.
  • It is a reasonable antibiotic alternative for pets allergic to penicillin or in conditions where penicillin has failed to treat the condition.
  • Following oral administration, azithromycin is rapidly absorbed and widely distributed throughout the body. Azithromycin’s bioavailability is 97% in dogs, 58% in cats, and its protein binding is 7 to 51%, depending on the plasma concentration.
  • Rapid distribution of azithromycin into tissues results in significantly higher azithromycin levels than in plasma. The half-life of azithromycin is long, lasting up to 90 hours in dogs. In cats, the tissue half-life is 13 to 72 hours, depending on the tissue. Azithromycin undergoes some hepatic metabolism, but the majority of an administered dose is excreted unchanged in bile.
  • Azithromycin is a prescription drug and can only be obtained from a veterinarian or by prescription from a veterinarian. It is not a controlled substance.
  • Azithromycin is registered for use in humans only. This drug is not approved for use in animals by the Food and Drug Administration (FDA), but it is prescribed legally by veterinarians as an extra-label drug.

Looking for a quick and convenient way to get your pet’s prescriptions delivered to your doorstep? Chewy’s pet pharmacy is a one-stop-shop for all of your pet care needs, offering a wide variety of prescription food and medication straight from the manufacturer, compound medications made just for your pet, and an Autoship option, so you never have to remember to order refills.

Brand Names and Other Names for Azithromycin

  • Human formulations: Multiple human preparations include Zithromax® (Pfizer), Zithro, Zaraxin, Clamelle, Zedbac, Zmax, AzaSite, as well as various generic formulations.
  • Veterinary formulations: None

Uses of Azithromycin for Dogs and Cats

The most common uses of azithromycin in pets are for the treatment of infections caused by susceptible microorganisms involving the skin, respiratory tract, and urogenital systems. Additional uses are for the treatment of otitis media (inner ear infections), bacterial causes of keratitis and conjunctivitis, cyclosporine-induced gingival hyperplasia, acute cytauxzoonosis, toxoplasmosis, and Babesia gibsoni infections. There is also evidence that azithromycin may aid in the treatment of viral papillomatosis in dogs.

Got questions about your pet’s prescription or health concerns in general? Chewy’s Connect with a Vet ™ service connects you directly with a licensed veterinarian to get answers to commonly asked questions, discuss health and wellness concerns, and get referrals to local vets and emergency clinics.

Key Points About Giving Azithromycin to Your Pet

  • Azithromycin is an antibiotic used in dogs and cats to treat respiratory, urinary, and skin infections.
  • Azithromycin is not available over the counter. It is a prescription drug and should only be administered under the guidance of a licensed veterinarian. A prescription can be obtained from your veterinarian and filled at veterinary hospitals or most human pharmacies.
  • The dosage, duration, and frequency of treatment varies depending upon the underlying condition, response to the medication, and the development of adverse effects.
  • Azithromycin can interact with other medications.
  • While generally safe and effective, azithromycin does have side effects in some pets with diarrhea being the most common.

Precautions and Side Effects

  • While azithromycin is generally safe and effective when prescribed by a veterinarian, it can cause side effects in some animals. Most importantly, azithromycin should not be used in animals with known hypersensitivity or an allergy to azithromycin or other macrolide antibiotics. Note: Other macrolides include clarithromycin, erythromycin, and roxithromycin. If your pet has had a reaction to any of these medications, inform your veterinarian immediately.
  • It is important to understand the general principles of antibiotic usage and that frequent or prolonged administration can lead to resistant infections. Your veterinarian will help guide you to what is appropriate for your pet.
  • Although azithromycin is commonly used in dogs and cats, it was created for and is licensed for use in humans only. Therefore, most available research focuses on human use and side effects. There is substantial documentation of liver problems including hepatotoxicity and cholestatic jaundice in humans. Additional side effects in humans include hearing abnormalities, taste or smell loss, angioedema, severe diarrhea caused by Clostridium difficile, and aggravation of myasthenia gravis symptoms.
  • In dogs and cats, azithromycin should be used with great caution (if at all) when there is a pre-existing hepatic (liver) or renal (kidney) disease and avoided with the failure of these organs. The most common side effects relate to the gastrointestinal tract, such as vomiting, diarrhea, or abdominal pain. Cardiac arrhythmias, including ventricular tachycardia, may be precipitated by azithromycin. Renal dysfunction, including interstitial nephritis and acute renal failure, may occur secondary to azithromycin treatment and liver function may be affected. Eye irritation may occur in pets receiving the ophthalmic formulation. Ergot toxicity may occur when ergotamine or dihydroergotamine are concurrently administered with azithromycin.
  • Note: Call your vet for recommendations if you believe your pet is suffering from an adverse reaction.

Drug Interactions

Azithromycin can interact with certain medications that include:

  • Azithromycin may elevate serum digoxin levels in cardiac patients taking digoxin. It can also increase serum levels of theophylline and methylprednisolone.
  • Azithromycin can cause a decrease in the clearance of triazolam and midazolam, increasing pharmacologic effects.
  • Pimozide is contraindicated in patients receiving azithromycin, and vice versa (death may result).
  • Animals being treated with cisapride should not be given azithromycin or other macrolide antibiotics.
  • Drugs metabolized by cytochrome P450 (e. g., carbamazepine, terfenadine, cyclosporine, hexobarbital, and phenytoin) will have their serum levels elevated by azithromycin.
  • Oral antacids reduce the absorption of azithromycin. When used, drugs should be separated from each other by 2 to 3 hours.
  • Azithromycin is incompatible with chloramphenicol when given via subcutaneous route.
  • Phenobarbital, a common seizure medication, can alter metabolic enzymes, resulting in ineffective azithromycin therapy.
  • Other drugs that should be used with caution include sotalol, ondansetron, dolesetron, ketoconazole, itraconazole, and enrofloxacin.
  • If your pet is taking any of the medications listed above, discuss the use of azithromycin with your veterinarian. They can help you understand the risk relative to the benefit and if this is the right medication for your pet.

How Azithromycin Is Supplied and Stored

Most veterinary and human pharmacies inventory tablet sizes (250 and 500 mg) and powder for oral suspension (200 mg/5 mL). Other formulations are generally available by special order.

Azithromycin is supplied as:

  • Tablets: 250 mg, 500 mg, and 600 mg film-coated oral tablets. Can be stored at room temperature.
  • Capsules: 250 mg. Can be stored at room temperature.
  • Powder for injection: 500 mg (lyophilized) in 10 mL vials. Stable for 7 days when reconstituted and stored under refrigeration and for 24 hours when stored at or below 86 degrees Fahrenheit.
  • Powder for oral suspension: 100 mg/5 mL, 200 mg/5mL, & 1 g/packet. Store between 41- and 86-degrees Fahrenheit.
  • Ophthalmic solution: 1% in 2.5 mL bottle. Should be refrigerated and discarded 14 days after opening. For topical use only.
  • Toothpaste: Azithromycin toothpastes may be made at compounding pharmacies in strengths that range from 5% to 8.5% in a variety of flavors. For oral use only.

Dosing Information on Azithromycin for Dogs and Cats

  • Azithromycin should never be administered without first consulting your veterinarian. It is a prescription product and cannot be purchased over the counter. It may be given with or without food. For pets that suffer from nausea, vomiting, or diarrhea, it is better to give medication with food. If you miss a dose of azithromycin, give the next dose as scheduled. Do not double the dose.
  • The dosage recommended for your pet will vary depending upon the underlying condition being treated. For example, it may be dosed at 15 mg/kg twice daily for 7 days in dogs with a coccidiosis infection or dosed at 5 mg/kg once daily for dogs with a Giardia infection.
  • While there is a substantial variation in dosages, the usual dosage in dogs is 2.5 to 5 mg per pound (5 to 10 mg/kg) orally once daily for up to 7 days. In cats, the usual dosage is 2.5 to 7.5 mg per pound (5 to 15 mg/kg) orally every 12 to 24 hours for up to 7 days. Some veterinarians may recommend gradually decreasing the frequency to every 3 to 5 days for a series of doses when treating some conditions (such as respiratory infections in cats).
  • Again, the dosage and duration of administration depends on the condition being treated, response to the medication, and the development of adverse effects. Be certain to complete the prescription unless specifically directed by your veterinarian. Even if your dog or cat feels better, the entire treatment plan should be completed to prevent relapse.

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Dr. Nicholas Dodman

April 27, 2022

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Arbidol Maximum – instructions for use

Dosage 200 mg – capsules No. 10 from white or white with a greenish-yellow or cream color to light yellow or light yellow with a greenish tint.

  • Treatment: 200 mg x 4 times a day, 5 days
  • Post-exposure prophylaxis: 200 mg x once a day, 10-14 days
  • Seasonal prophylaxis: 200 mg x 2 times a week, 3 weeks

Download instructions

Registration number: LP-002690 dated 10/31/2014

Trade name of the drug: Arbidol ® Maximum

9 0002 International nonproprietary name: Umifenovir

Dosage form: capsules

Composition per capsule:

Active ingredient : umifenovir hydrochloride monohydrate (calculated as umifenovir hydrochloride) – 207 mg (calculated as umifenovir hydrochloride) – 200 mg.

Excipients: potato starch – 45.67 mg, microcrystalline cellulose – 11.20 mg, colloidal silicon dioxide (aerosil) – 2.80 mg, povidone (collidone 25) – 7.73 mg, calcium stearate – 2 .80 mg, croscarmellose sodium – 2.80 mg, capsule content weight – 280 mg.

Hard gelatin capsules No. 0:

The composition of the capsule shell (body and cap): titanium dioxide (E 171) – 1.92 mg, gelatin – 94.08 mg. The total weight of the capsule is 376 mg.

Description

White No. 0 hard gelatin capsules. The contents of the capsule is a mixture containing granules and powder from white or white with a greenish-yellow or cream color to light yellow or light yellow with a greenish tint.

Pharmacotherapeutic group: antiviral agent.

ATC code: J05AX13

Pharmacological properties

Pharmacodynamics

Antiviral agent. Specifically suppresses in vitro influenza A and B viruses ( Influenza virus A, B ), including highly pathogenic subtypes A ( h2 N1) pdm09 and A( H5 N1) , as well as other viruses that cause acute respiratory viral infections (ARVI) (coronavirus ( С oronavirus ), associated with severe acute respiratory syndrome (SARS), rhinovirus ( Rhinovirus ), adenovirus ( Adenovirus ), respiratory syncytial virus ( Pneumovirus ) and parainfluenza virus ( Paramyxovirus )). In in vitro studies, specifically inhibits the SARS-CoV-2 virus that causes the novel coronavirus infection (COVID-19).). The EC50 (half maximum effective concentration) in Vero E6 cells is 4.11 µmol, which corresponds to 2.11 µg/mL. The clinical significance of this requires further study.

According to the mechanism of antiviral action, it belongs to fusion (fusion) inhibitors, interacts with the hemagglutinin of the virus and prevents the fusion of the lipid envelope of the virus and cell membranes. It has a moderate immunomodulatory effect, increases the body’s resistance to viral infections. It has interferon-inducing activity – in a study on mice, the induction of interferons was noted already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral immune reactions: increases the number of lymphocytes in the blood, especially T-cells (CD3), increases the number of T-helpers (CD4), without affecting the level of T-suppressors (CD8), normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killer (NK-cells).

Therapeutic efficacy in viral infections is manifested in a decrease in the duration and severity of the course of the disease and its main symptoms, as well as in a decrease in the incidence of complications associated with a viral infection and exacerbations of chronic bacterial diseases.

In the treatment of influenza or acute respiratory viral infections in adult patients in a clinical study, it was shown that the effect of the drug in adult patients is most pronounced in the acute period of the disease and is manifested by a reduction in the resolution of symptoms of the disease, a decrease in the severity of the manifestations of the disease and a reduction in the elimination of the virus.

Therapy with the drug leads to a higher frequency of relief of symptoms of the disease on the third day of therapy compared with placebo – 60 hours after the start of therapy, the resolution of all symptoms of laboratory-confirmed influenza is more than 5 times higher than in the placebo group.

A significant effect of the drug on the rate of elimination of the influenza virus was established, which, in particular, was manifested by a decrease in the frequency of detection of virus RNA on the 4th day.

Refers to low toxicity drugs (LD50 > 4 g/kg). It does not have any negative effects on the human body when taken orally at recommended doses.

Pharmacokinetics

Rapidly absorbed and distributed throughout organs and tissues. The maximum plasma concentration when taken at a dose of 50 mg is reached after 1.2 hours, at a dose of 100 mg – after 1.5 hours. It is metabolized in the liver. The elimination half-life is on average 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in a small amount by the kidneys (0.12%). During the first day, 90% of the administered dose is excreted.

Indications for use

Prevention and treatment in adults and children from 12 years of age: influenza A and B, other SARS.

Complex therapy of recurrent herpetic infection.

Prevention of postoperative infectious complications.

Complex therapy of acute intestinal infections of rotavirus etiology in children over 12 years old.

Contraindications

Hypersensitivity to umifenovir or any component of the formulation; children’s age up to 12 years. First trimester of pregnancy. breastfeeding period.

Precautions

Second and third trimesters of pregnancy.

Use during pregnancy and lactation

In animal studies, no adverse effects on pregnancy, embryonic and fetal development, labor and postnatal development have been identified.

The use of the drug Arbidol ® Maximum in the first trimester of pregnancy is contraindicated.

In the second and third trimester of pregnancy Arbidol ® Maximum may only be used for the treatment and prevention of influenza and if the expected benefit to the mother outweighs the potential risk to the fetus. The benefit / risk ratio is determined by the attending physician.

It is not known whether Arbidol ® Maximum passes into breast milk in lactating women. If necessary, the use of Arbidol ® Maximum should stop breastfeeding.

Dosage and administration

Inside, before meals.

Single dose for adults and children over 12 years old – 200 mg (1 capsule).

Reading

Regimen

Adults and children over 12:

Non-specific prophylaxis during influenza and other acute respiratory viral infections

single dose
2 times a week for 3 weeks.

Non-specific prophylaxis by direct contact with patients with influenza and other acute respiratory viral infections

single dose
1 time per day for 10-14 days.

Treatment of influenza and other acute respiratory viral infections

single dose
4 times a day
(every 6 hours) for 5 days.

Complex therapy of recurrent herpetic infection

single dose
4 times a day
(every 6 hours) for 5-7 days, then in a single dose 2 times a week for 4 weeks.

Prevention of postoperative infectious complications

single dose
2 days before surgery, then 2 and 5 days after surgery.

Children from 12 years of age:

Complex therapy of acute intestinal infections of rotavirus etiology

single dose
4 times a day
(every 6 hours) for 5 days.

Start taking the drug from the moment the first symptoms of influenza and other acute respiratory viral infections appear, preferably no later than 3 days from the onset of the disease.

If after using the drug Arbidol ® for a maximum of three days in the treatment of influenza and other acute respiratory viral infections, the severity of symptoms of the disease persists, including high fever (38 ° C or more), then you need to consult a doctor to assess the validity of taking the drug.

Use the drug only for the indications, for the method of use and at the doses indicated in the instructions.

In the treatment of influenza and ARVI, concomitant symptomatic therapy is possible, including the use of antipyretic drugs, mucolytic and local vasoconstrictors.

Side effects

Arbidol ® Maximum refers to low toxicity drugs and is usually well tolerated.

Side effects are rare, usually mild to moderate and transient.

The frequency of occurrence of adverse drug reactions was determined in accordance with the WHO classification: very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with a frequency of at least 1/10 1000, but less than 1/100), rarely (with a frequency of at least 1/10000, but less than 1/1000), very rarely (with a frequency of less than 1/10000), the frequency is unknown (cannot be established from the available data).

Immune system disorders : rarely – allergic reactions.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Not reported.

Interaction with other drugs

When administered with other drugs, no adverse effects were noted.

Special clinical studies devoted to the study of interactions of the drug Arbidol ® Maximum with other drugs have not been conducted.

Data on the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs were not identified in the conditions of a clinical study.

Special instructions

It is necessary to follow the regimen recommended in the instructions and the duration of taking the drug. In case of missing one dose of the drug, the missed dose should be taken as soon as possible and the course of taking the drug should be continued according to the started scheme.

If after using the drug Arbidol ® for a maximum of three days in the treatment of influenza and other acute respiratory viral infections, the severity of the symptoms of the disease persists, including high fever (38 ° C or more), then you need to consult a doctor to assess the validity of taking the drug.

Influence on the ability to drive vehicles and mechanisms

It does not show central neurotropic activity and can be used in medical practice in people of various professions, incl. requiring increased attention and coordination of movements (transport drivers, operators, etc.).

Product form

Capsules 200 mg.

10 capsules in a blister pack made of PVC film and printed lacquered aluminum foil.

1 or 2 blister packs with instructions for use are placed in a pack of cardboard.

Storage conditions

Store below 25°C. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiry date stated on the packaging.

Terms of sale

Available without a prescription.

Marketing authorization holder/organization accepting customer complaints

OTCPharm JSC, Russia
123112, Moscow, st. Testovskaya, 10
this. 12, room II, com. 29
Tel.: +7 (800) 775-98-19
Fax: +7 (495) 221-18-02
www.otcpharm.ru
www.arbidol.ru

Producer

JSC “Pharmstandard-Leksredstva”
305022, Russia, Kursk,
st. 2nd Aggregatnaya, 1а/18,
tel./fax: (4712) 34-03-13,
www.pharmstd.ru

Noopept: instructions for use

Registration number: LS-001577-180711
Brand name: Noopept®
Active ingredient: Omberacetam
Chemical name: N-phenylacetyl-L-prolylglycine ethyl ester
Dosage form: tablets

Download
instructions

Composition per tablet

Active ingredient: Omberacetam (noopept) – 10. 0 mg; excipients: lactose monohydrate – 55.0 mg, potato starch – 13.5 mg, microcrystalline cellulose 101 – 21.2 mg, magnesium stearate – 0.3 mg, povidone (polyvinyl pyrrolidone, povidone K-25) – 0.0008 mg.

Description

White, round, flat-cylindrical tablets with a bevel.

Pharmacotherapeutic group: nootropic agent. Noopept® has nootropic and neuroprotective properties. Improves learning ability and memory, acting on all phases of processing: initial processing of information, consolidation, extraction. Prevents the development of amnesia caused by electric shock, blockade of the central cholinergic structures, glutamatergic receptor systems, deprivation of the paradoxical phase of sleep. The neuroprotective (protective) effect of Noopept® is manifested in an increase in the resistance of brain tissue to damaging effects (trauma, hypoxia, electroconvulsive, toxic) and a decrease in the degree of damage to brain neurons. The drug reduces the volume of the focus in the thrombotic model of stroke and prevents the death of neurons in the tissue culture of the cerebral cortex and cerebellum exposed to neurotoxic concentrations of glutamate, free radical oxygen. Noopept® has an antioxidant effect, blocks voltage-dependent calcium channels of neurons, weakening the neurotoxic effect of excess calcium, improves the rheological properties of blood, having antiplatelet, fibrinolytic, anticoagulant properties.

The nootropic effect of the drug is associated with the formation of cycloprolylglycine, similar in structure to the endogenous cyclic dipeptide, which has antiamnestic activity, as well as with the presence of anticholinergic action.

Noopept® increases the amplitude of the transcallosal response, facilitating associative connections between the cerebral hemispheres at the level of cortical structures. It helps to restore memory and other cognitive functions impaired as a result of damaging effects – brain injury, local and global ischemia, prenatal damage (alcohol, hypoxia).

The therapeutic effect of the drug in patients with organic disorders of the central nervous system is manifested starting from the 5th-7th day of treatment. Initially, the anxiolytic and light stimulating effects present in the spectrum of activity of Noopept® are realized, manifested in the reduction or disappearance of anxiety, increased irritability, affective lability, and sleep disturbances. After 14-20 days of therapy, a positive effect of the drug on cognitive functions, attention and memory parameters is revealed.

Noopept® has a vegetative normalizing effect, helps to reduce headaches, orthostatic disorders, tachycardia.

When the drug is discontinued, there is no “withdrawal” syndrome.

Does not have a damaging effect on internal organs; does not lead to a change in the cellular composition of the blood and biochemical parameters of blood and urine; does not have immunotoxic, teratogenic effects, does not show mutagenic properties.

Pharmacokinetics

Omberacetam, being absorbed in the gastrointestinal tract, enters the systemic circulation unchanged, penetrates the blood-brain barrier, and is determined in the brain at higher concentrations than in the blood. The time to reach the maximum concentration is on average 15 minutes. The plasma half-life is 0.38 hours. It is partially preserved unchanged, partially metabolized to form phenylacetic acid, phenylacetylproline and cycloprolylglycine. It has a high relative bioavailability (99.7%), does not accumulate in the body, does not cause drug dependence.

Indications for use

Impairments of memory, attention, other cognitive functions and emotionally labile disorders (including in elderly patients) with:

  • consequences of traumatic brain injury,
  • postconcussion syndrome,
  • cerebrovascular insufficiency (encephalopathies of various origins),
  • asthenic disorders,
  • other conditions with signs of reduced intellectual productivity.

Contraindications

Pregnancy, breastfeeding. Age up to 18 years. Hypersensitivity to the components of the drug. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption. Pronounced violations of the liver and kidneys.

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy.

If it is necessary to use the drug during breastfeeding, it is necessary to resolve the issue of stopping breastfeeding.

Dosage and Administration

Noopept® is used orally, after meals. Treatment begins with a dose of 20 mg divided into two doses of 10 mg during the day (morning and afternoon). With insufficient effectiveness of therapy and with good tolerability of the drug, the dose is increased to 30 mg (see “Special Instructions”), distributing it into three doses of 10 mg during the day. Do not take the drug later than 18 hours. The duration of the course of treatment is 1.5 – 3 months. A second course of treatment, if necessary, can be carried out after 1 month.

Side effects

Allergic reactions possible. In patients with arterial hypertension, mostly severe, while taking the drug, there may be an increase in blood pressure.

Overdose

No specific manifestations of overdose have been established.

Interaction with other medicinal products

Interaction of Noopept® with alcohol, hypnotics and antihypertensives and psychoactive drugs has not been established.

Special instructions

If you need to increase the dose of the drug (up to 30 mg / day), with prolonged use, as well as with simultaneous use with other drugs, the appearance of adverse reactions or deterioration, you should consult a doctor.

Influence on the ability to drive vehicles, mechanisms

Noopept® does not affect the ability to drive mechanisms and vehicles.

Presentation

Tablets, 10 mg.

25 tablets in a blister pack made of PVC film and aluminum foil.

2 blister packs, together with instructions for use, are placed in a pack of cardboard.

Storage conditions

At temperatures not exceeding 25°C.

Keep out of reach of children.