Ambisome Lyophilisate For Suspension For Injection 50Mg Drug Medication Dosage Information
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AmBisome: Lyophilisate for suspension for injection (50mg)

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What is this Medicine?

AMPHOTERICIN (am foe TER i sin) B LIPOSOMAL INJECTION is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections.

In-Depth Information

AmBisome 50mg Powder for Injection

NDC: 004693051
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Pneumonia, Peritonitis, Meningitis, Aspergillosis, Pericarditis, Myocarditis, Endocarditis, Candidiasis, Infectious Arthritis, Candidemia, Osteomyelitis, Cryptococcosis, Tracheobronchitis, Febrile Neutropenia, Fungal Keratitis, Esophageal Candidiasis, Leishmaniasis, Endophthalmitis, Sinusitis

Sometimes used for but not FDA approved for the following conditions:
Candidiasis Prophylaxis, Blastomycosis, Histoplasmosis, Coccidioidomycosis, Penicilliosis

Storage Information
Reconstituted product should be refrigerated and used within 24 hours if not used immediately
Discard product if it contains particulate matter, is cloudy, or discolored
Do not freeze reconstituted product
Store unreconstituted product at or below 77 degrees F
AmBisome 50mg Powder for Injection

Reported Side Effects for AmBisome 50mg Powder for Injection

Hypoxia Incidence:
0.3-7.6%*
Severity: MODERATE
Onset: EARLY
Overbreathing Incidence:
1.2%*
Severity: MILD
Onset: EARLY
Abnormal Heart Rhythm Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: EARLY
Blistery Rash Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: EARLY
Conjunctivitis Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Dysesthesia Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Dystonic Reaction Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Vaginal Bleeding Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Convulsions Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Flu Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
High Chloride Level Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Difficulty Swallowing Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Coagulopathy Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Bleeding Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: EARLY
Dry Mouth Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Dry Skin Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Dry Eyes Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Hives Incidence:
2.0-10.0%*
Severity: MILD
Onset: RAPID
Vesicular Rash Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Veno-occlusive Disease (VOD) Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Skin Ulcer Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Skin Discoloration Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Kidney Failure Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Bruises Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Red Spotted Rash Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Peripheral Vasodilation Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: RAPID
Paresthesias Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Bleeding Within The Eye Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Dry Nose Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Rash With Pustules Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
2.0-10.0%*
Severity: MILD
Onset: RAPID
Hiccups Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Enlarged Liver Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Coughing Up Blood Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Vomiting Of Blood Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Hallucinations Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: EARLY
Flushing Incidence:
2.0-10.0%*
Severity: MILD
Onset: RAPID
Fluid Retention Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Fecal Incontinence Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: EARLY
Belching Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Bruise Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
High Phosphate Levels Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
High Magnesium Level Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
High Potassium Level Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Hemorrhoids Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Low Phosphate Level Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Gas Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Painful Urination Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: EARLY
Bowel Obstruction Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Upset Stomach Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Electrolyte Imbalance Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Drowsiness Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Muscle Pain Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Coma Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: EARLY
Suddenly Stopped Heart Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: EARLY
Slow Heart Beat Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: RAPID
Postural Low Blood Pressure Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Bone Pain Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Irregular Heart Beat Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: EARLY
Sore Throat Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Fluid In Lungs Incidence:
2.0-10.0%*
Severity: SEVERE
Onset: EARLY
Sinus Infection Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Hair Loss Incidence:
2.0-10.0%*
Severity: MILD
Onset: DELAYED
Mouth Ulcers Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Distressed Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Shaking Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Uncontrolled Urination Incidence:
2.0-10.0%*
Severity: MODERATE
Onset: EARLY
Cough Incidence:
2.1-17.8%*
Severity: MILD
Onset: DELAYED
High Blood Pressure Incidence:
2.3-19.8%*
Severity: MODERATE
Onset: EARLY
Rapid Heart Rate Incidence:
2.3-18.5%*
Severity: MODERATE
Onset: RAPID
Low Blood Pressure Incidence:
3.5-14.3%*
Severity: MODERATE
Onset: RAPID
High Sodium Levels Incidence:
4.1%*
Severity: MODERATE
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
4.3-14.6%*
Severity: MODERATE
Onset: DELAYED
Skin Rash Incidence:
4.7-24.8%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
4.7-23.0%*
Severity: MODERATE
Onset: EARLY
Low Calcium Levels Incidence:
4.9-18.4%*
Severity: MODERATE
Onset: DELAYED
Low Platelet Count Incidence:
5.8-12.8%*
Severity: MODERATE
Onset: DELAYED
Chills Incidence:
6.0-48.1%*
Severity: MILD
Onset: RAPID
Weakness Incidence:
6.2-13.1%*
Severity: MILD
Onset: DELAYED
Low Potassium Levels Incidence:
6.7-51.1%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
7.0-19.8%*
Severity: MILD
Onset: EARLY
Fever Incidence:
7.0-23.5%*
Severity: MILD
Onset: EARLY
Excessive Sweating Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
7.0-8.5%*
Severity: MILD
Onset: EARLY
Nervousness Incidence:
7.4-13.7%*
Severity: MILD
Onset: DELAYED
Low Kidney Function Incidence:
7.4-21.0%*
Severity: SEVERE
Onset: DELAYED
Chest Pain Incidence:
8.2-12.0%*
Severity: MODERATE
Onset: EARLY
Increased Blood Sugar Incidence:
8.2-23.0%*
Severity: MODERATE
Onset: DELAYED
Increased Blood Volume Incidence:
8.2-12.2%*
Severity: MODERATE
Onset: DELAYED
Low Blood Sodium Levels Incidence:
8.5-11.6%*
Severity: MODERATE
Onset: DELAYED
High Bilirubin Level Incidence:
8.5-18.1%*
Severity: MODERATE
Onset: DELAYED
Confusion Incidence:
8.6-11.4%*
Severity: MODERATE
Onset: EARLY
Nose Bleed Incidence:
8.6-14.9%*
Severity: MILD
Onset: DELAYED
Irritated Blood Vessels Incidence:
9.3-10.6%*
Severity: MODERATE
Onset: RAPID
Headache Incidence:
9.4-19.8%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
9.6-14.0%*
Severity: MILD
Onset: DELAYED
Intestinal Bleeding Incidence:
9.9%*
Severity: SEVERE
Onset: DELAYED
Loose Stools Incidence:
10.5-30.3%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
10.5-31.8%*
Severity: MILD
Onset: EARLY
Itching Incidence:
10.8%*
Severity: MILD
Onset: RAPID
Infection Incidence:
11.1-12.8%*
Severity: MILD
Onset: DELAYED
Rhinitis Incidence:
11.1%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Swelling Incidence:
12.3-14.3%*
Severity: MODERATE
Onset: DELAYED
Fluid Around The Lungs Incidence:
12.5%*
Severity: SEVERE
Onset: DELAYED
Blood In The Urine Incidence:
14.0%*
Severity: MODERATE
Onset: DELAYED
Fluid Retention Incidence:
14.6%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
14.9-15.1%*
Severity: MODERATE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
15.1-17.0%*
Severity: MODERATE
Onset: DELAYED
Low Magnesium Levels Incidence:
15.3-48.9%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
16.3-39.7%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
17.0-22.1%*
Severity: MILD
Onset: EARLY
Anemia Incidence:
26.7-47.9%*
Severity: MODERATE
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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