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Sitavig

Sitavig (acyclovir) is used to treat herpes labialis (cold sores). Includes Sitavig side effects, interactions and indications.
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Drug Information:
The U.S. Food and Drug Administration (FDA) has approved Sitavig (acyclovir) buccal tablets for the treatment of recurring Herpes labialis Based on proprietary Lauriad® technology, Sitavig comes in the form of a mucoadhesive tablet which the patient places on the gum and which delivers a high concentration of acyclovir directly to the lip, the site of the cold sore infection. In a phase III international study conducted on 775 patients, Sitavig demonstrated a high level of efficacy in terms of healing time with one single tablet containing 50 mg of acyclovir and an excellent tolerance profile. In addition to its efficacy, Sitavig offers a unique unobtrusive and simple formulation with a single application for the episode's entire duration, representing major advantages for patients suffering from recurrent herpes sores. Learn more

Sitavig Side Effects

Sitavig Side Effects

Note: This document contains side effect information about acyclovir. Some of the dosage forms listed on this page may not apply to the brand name Sitavig.

For the Consumer

Applies to acyclovir: capsule, powder for solution, solution, suspension, tablet

Other dosage forms:

  • buccal mucosa tablet

Along with its needed effects, acyclovir (the active ingredient contained in Sitavig) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acyclovir:

More common

- For acyclovir injection only
  • Pain, swelling, or redness at place of injection

Less common

  • Abdominal or stomach pain
  • decreased frequency of urination or amount of urine
  • increased thirst
  • loss of appetite
  • nausea or vomiting
  • unusual tiredness or weakness

Rare

  • Black, tarry stools
  • blood in urine or stools
  • chills, fever, or sore throat
  • confusion
  • convulsions (seizures)
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • hives
  • pinpoint red spots on skin
  • trembling
  • unusual bleeding or bruising

Frequency not determined

  • Bleeding or oozing from puncture sites or mucous membranes (bowel, mouth, nose, or urinary bladder), continuing
  • blistering, peeling, or loosening of skin
  • bluish coloring, especially of the hands and feet
  • blurred vision
  • bruising at the place of injection
  • changes in facial skin color
  • changes in vision
  • clumsiness
  • coughing
  • decreased consciousness
  • difficulty in breathing or swallowing
  • dizziness or feeling faint, severe
  • fast heartbeat
  • irritability
  • itching or skin rash
  • large hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • mood or mental changes
  • muscle cramps, pain, or weakness
  • pale skin
  • red or irritated eyes
  • sense of agitation or uneasiness
  • shakiness and unsteady walk
  • sores, ulcers, or white spots in mouth or on lips
  • swelling of eyelids, face, feet, hands, lower legs or lips
  • swollen, painful, or tender lymph nodes (glands) in neck, armpit, or groin
  • unsteadiness or other problems with muscle control or coordination
  • yellow eyes or skin

Some side effects of acyclovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

- Especially seen with high doses
  • General feeling of discomfort or illness

Less common

- Especially seen with long-term use or high doses
  • Diarrhea
  • headache

Frequency not determined

  • Burning, prickling, or tingling sensations
  • drowsiness
  • loss of hair

For Healthcare Professionals

Applies to acyclovir: buccal tablet, compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral suspension, oral tablet

General

The more commonly reported adverse reactions include malaise, nausea, vomiting, diarrhea, and headache.

Gastrointestinal

Nausea and vomiting are more frequent in elderly subjects.

Common (1% to 10%): Nausea, vomiting, diarrhea, abdominal pain, gingival pain (buccal tablet), aphthous stomatitis (buccal tablet)

Uncommon (0.1% to 1%): Sore throat

Postmarketing reports: Gastrointestinal distress

Renal

Rare (0.01% to 0.1%): Elevated blood urea nitrogen, elevated creatinine,

Very rare (less than 0.01%): Acute renal failure, renal pain

Frequency not reported: Crystalluria, renal impairment

Postmarketing reports: Renal failure, hematuria

Renal pain may be associated with renal failure and crystalluria. Renal impairment is generally reversible but may progress to acute renal failure.

Local

Common (1% to 10%): Application site pain and application site irritation, local inflammation at injection site, phlebitis

Frequency not reported: Tissue necrosis

Severe local inflammatory reactions, including tissue necrosis, have occurred following infusion into extravascular tissues. Application site pain and application site irritation have occurred with the buccal tablets.

Nervous system

Dizziness, somnolence, and coma more frequent in elderly subjects.

Common (1% to 10%): Headache, dizziness

Very rare (less than 0.01%): Ataxia, coma, convulsions, encephalopathy, dysarthria

Frequency not reported: Giddiness, shaking, taste disturbance, medication taste

Postmarketing reports: Decreased consciousness, delirium, paresthesia, seizure, tremors

Dermatologic

Common (1% to 10%): Erythema, rashes (including photosensitivity), pruritus, hives

Uncommon (0.1% to 1%): Urticaria, accelerated diffuse hair loss

Frequency not reported: Diaphoresis

Postmarketing reports: Alopecia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Cardiovascular

Frequency not reported: Palpitation, chest pain

Postmarketing reports: Hypotension, peripheral edema

Hematologic

Very rare (less than 0.01%): Anemia, leukopenia, thrombocytopenia, neutropenia

Frequency not reported: Hematologic changes including megaloblastic anemia

Postmarketing reports: Leukocyclastic vasculitis, lymphadenopathy, disseminated intravascular coagulation, hemolysis

Hepatic

Rare (0.01% to 0.1%): Reversible bilirubin and liver related enzymes

Very rare (less than 0.01%): Hepatitis, jaundice

Postmarketing reports: Hyperbilirubinemia

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis

Frequency not reported: Angioedema

Ocular

Frequency not reported: Pars planitis

Postmarketing reports: Visual abnormalities

Musculoskeletal

Uncommon (0.1% to 1%): Leg pain

Postmarketing reports: Myalgia

Other

Common (1% to 10%): Lethargy, fatigue, fever

Frequency not reported: Vertigo

Postmarketing reports: Fever

Genitourinary

Frequency not reported: Menstrual abnormalities, abnormal urinalysis (characterized by an increase in formed elements in urine sediment) anuria, dysuria, hematuria

Metabolic

Uncommon (0.1% to 1%): Anorexia

Frequency not reported: Thirst

Psychiatric

Hallucinations, psychosis, confusion, aggressive behavior, agitation may be more marked in older adults and those with renal impairment.

Very rare (less than 0.01%): Agitation, confusion, hallucinations, psychotic symptoms

Frequency not reported: Depression, insomnia

Postmarketing reports: Aggressive behavior

Respiratory

Rare (0.01% to 0.1%): Dyspnea

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Sitavig