Cefdinir - Uses, Dosage, Side Effects, and Drug Warnings

Overview

Cefdinir is a third-generation cephalosporin with in vitro activity against pathogens that cause community-acquired infections. The drug gives excellent coverage against Moraxella catarrhalis, Haemophilus influenza, and Penicillin-susceptible Streptococcus pneumonia, the most common respiratory tract pathogens. The drug is distributed to tissues (sinus and tonsils) and fluids (middle ear). Cefdinir is usually administered for five or ten days. It has shown good clinical and bacteriological effects for mild-to-moderate respiratory tract and skin injections.

Drug Group:

The active ingredient in Cefdinir capsules is a semisynthetic cephalosporin, an extended-spectrum, for oral administration. Cefdinir comes as a white to slightly brownish-yellow solid. The molecular weight is 395.42, and the empirical formula is C14H13N5O5S2. It shows slight solubility in dilute hydrochloric acid and is sparingly soluble in 0.1 M pH 7.0 phosphate buffer.

Available Doses and Dosage Forms:

Cefdinir is available in the following doses and forms:

1. Capsule:

• 300 milligrams (mg).

2. Oral Suspension:

• 125 milligrams per 5 milliliters (mg/mL).

• 250 milligrams per 5 milliliters.

a) Community-Acquired Pneumonia: 300 milligrams every 12 hours for 10 days orally.

(For disease caused by Haemophilus influenza, Haemophilus, Streptococcus pneumonia, or Moraxella catarrhalis).

b) Respiratory Tract Infections: 300 milligrams (orally) every 12 hours for five to ten days or 600 milligrams (orally) every 24 hours for 10 days.

(For acute exacerbations of chronic bronchitis caused by H. influenza, H. parainfluenza, S. pneumonia, or M. catarrhalis; pharyngitis and tonsillitis caused by Streptococcus pyogenes).

c) Acute Maxillary Sinusitis: 300 milligrams (orally) every 12 hours or 600 milligrams (orally) every 24 hours for ten days.

(For disease caused by H. influenza, S. pneumonia, or M. catarrhalis).

d) Skin or Skin Structure Infections: 300 milligrams 12 hours for 10 days orally.

(For uncomplicated infections caused by Staphylococcus aureus or S. pyogenes).

Dosing Considerations

Renal Impairment:

• Creatinine clearance (CrCl) < 30 ml/min (adults): Not to exceed 300 mg/day orally.

• CrCl < 30 ml/min (children): 7 mg/kg every 24 hours; not to exceed 300 mg/day.

Hepatic Impairment:

• No dosage adjustment is required.

For Patients:

What Is Community-Acquired Pneumonia?

Community-acquired pneumonia is an acute infection of the lung parenchyma acquired outside of the hospital and is a major cause of morbidity and mortality around the globe. The clinical features of community-acquired pneumonia vary, ranging from mild pneumonia with fever and a productive cough to severe pneumonia with respiratory distress and sepsis.

How Does Cefdinir Work?

Cefdinir is used for treating some infections caused by bacteria, like pneumonia, bronchitis (lung infection of the airway tube), and infections of the skin, ears, sinuses, throat, and tonsils. Cefdinir belongs to a class of medications known as cephalosporin antibiotics. It acts by killing bacteria. Cefdinir is an antibiotic that does not work for flu, colds, or other viral infections.

What Is the Dosage of Cefdinir?

Cefdinir is available in the form of a capsule, suspension, or liquid to take by mouth. It is usually taken with or without food for five to ten days, every 12 or 24 hours. Cefdinir must be taken at the same time every day.

How Is Cefdinir Administered?

Cefdinir should be administered exactly as directed. The suspension must be shaken well before every use to evenly mix the medication. The patient usually starts feeling better during the initial period of treatment with Cefdinir. If the symptoms do not improve or get worse, the doctor must be consulted immediately. The patient must continue Cefdinir even if they feel better. The infection might not be treated completely if Cefdinir is stopped too soon or doses are skipped, and the bacteria can become resistant to antibiotics.

What Are the Side Effects of Cefdinir?

The side effects of Cefdinir include:

• Vomiting.

• Stomach pain.

• Nausea.

• Diarrhea.

• Headache.

• Vaginal itching.

• Reddish-colored stools.

Some side effects might be serious. If any of the following symptoms are experienced, the doctor must be informed immediately for emergency medical treatment:

• Rash or hives.

• Swelling of the face, tongue, throat, lips, or eyes.

• Difficulty breathing or swallowing.

• Stomach cramps, watery or bloody stools, or fever.

• Recurrence of fever, chills, sore throat, or other signs of infection.

Dietary Considerations:

The patient must inform the doctor about eating foods that have iron in them, like iron-fortified breakfast cereal, while Cefdinir is being administered. However, babies might be given iron-fortified infant formula during treatment with this medication.

Missed Dose:

The missed dose must be taken as soon as the patient remembers about it. However, if it is time for the next dose, the missed dose can be skipped, and the patient can continue with the regular dose schedule. A double dose must not be taken to compensate for the missed dose.

Overdose:

The following are the symptoms of an overdose:

• Nausea.

• Stomach pain.

• Vomiting.

• Diarrhea.

• Seizures.

Storage:

• The medication must be kept in the container that it comes in. It must be tightly closed and kept out of reach of children.

• The capsules and suspension must be stored at room temperature.

• The medication must be kept away from excess heat and moisture.

• The unused suspension must be disposed of after ten days.

• Unwanted medications must be disposed of properly to make sure that children, pets, and other people do not consume them.

For Doctors:

Indication:

Indications for Cefdinir in adults and adolescents include:

• Acute bacterial exacerbations of chronic bronchitis.

• Community-acquired pneumonia.

• Acute bacterial rhinosinusitis.

• Streptococcal pharyngitis.

• Respiratory tract infections.

• Uncomplicated skin infections.

Dose:

The dose of this medication differs between patients. The amount of medicine administered is associated with the strength of the medicine. Also, the number of doses given to the patient each day, the interval between doses, and the duration for which the medicine is taken depend on the medical condition for which the medication is administered.

For capsules or suspension (oral dosage forms):

For Infections:

• Adults and teenagers: 300 milligrams (mg) every twelve hours or 600 mg once daily for five to ten days.

• Infants and children six months up to 12 years of age: The doctor adjusts the dose according to the patient's body weight. The dose is usually seven mg per kg of body weight every twelve hours or 14 mg per kg of body weight per day for five to ten days. However, the dose is usually at most 600 mg per day.

• Infants up to six months of age: Use and dose must be adjusted by the doctor.

Dosing Considerations:

What Are the Pharmacological Aspects of Cefdinir?

Pharmacokinetics

Oral Bioavailability:

Maximal plasma Cefdinir concentrations are seen two to four hours after the capsule or suspension administration. Plasma Cefdinir concentrations rise as the dose is increased. Cefdinir bioavailability is 120 % after suspension administration to healthy adults compared to capsules. The estimated bioavailability of Cefdinir capsules is 21 % after administering a 300 mg capsule dose and 16 % after administering a 600 mg capsule. The absolute bioavailability of cefdinir suspension is 25 %. Cefdinir oral suspension of 250 mg per 5 mL strength was shown to be bioequivalent to 125 mg per 5 mL strength in healthy adults under fasting conditions.

Effect of Food:

The Cmax and AUC of Cefdinir from the capsules are decreased by 16 % and 10 % when administered with a high-fat meal, respectively. The Cmax and AUC of Cefdinir are decreased by 44 % and 33 % in adults administered the 250 mg per 5 mL oral suspension with a high-fat meal, respectively. The decrease in Cmax and AUC of Cefdinir does not hold any clinical significance because oral suspension's efficacy and safety studies in pediatric patients were done without considering food intake. Therefore, Cefdinir might be taken without regard to food.

Warnings and Precautions:

Drug History: The patient must inform the doctor if they take prescription or nonprescription medications, nutritional supplements, vitamins, and herbal products. The patient must mention if they are taking probenecid. The doctor might change the doses of the medications or monitor the side effects carefully.

The doctor must be informed if the patient is allergic to Cefdinir or any other cephalosporin antibiotic, like

• Cefaclor.

• Cefadroxil.

• Cefazolin.

• Cefditoren.

• Cefepime.

• Ceftriaxone.

• Cefotaxime.

• Cefixime.

• Cefotetan.

• Cefoxitin.

• Cefprozil.

• Ceftaroline.

• Cefpodoxime.

• Ceftazidime.

• Ceftibuten.

• Cefuroxime or Cephalexin.

• Penicillin antibiotics.

The doctor must be informed if the patient is allergic to Cefdinir capsules or suspension ingredients.

The patient must inform the doctor if they are taking antacids with iron supplements, magnesium or aluminum, or multivitamins containing iron, as they must be administered two hours before or two hours after Cefdinir.

Medical History: The patient must inform the doctor of any gastrointestinal disease affecting the stomach or intestines, particularly colitis that causes swelling in the colon or large intestine lining or kidney disease. In the case of diabetes, the patient must know that the Cefdinir suspension or solution contains sucrose or sugar.

Pregnant: The patient must inform the doctor about their pregnancy, whether they plan to become pregnant or are breastfeeding. The doctor must be consulted if the patient becomes pregnant while taking Cefdinir.

What Are the Drug Interactions of Cefdinir?

Various medications should not be used together. Sometimes, two medicines might be administered simultaneously, even if an interaction is anticipated. In these cases, the doctor might want to change the dose, or the patient might have other precautions. When this medicine is administered, the healthcare professional must be informed if the patient takes the following medications.

Using Cedinir with any of the following medicines is usually not recommended; however, it might be required in some cases. If both medications are prescribed, the doctor might alter the dose or the interval between the medicines.

• Cholera vaccine.

• Desogestrel.

• Drospirenone.

• Dienogest.

• Estradiol.

• Ethynodiol.

• Ethinyl Estradiol.

• Gestodene.

• Levonorgestrel.

• Mestranol.

• Methotrexate.

• Norethindrone.

• Nomegestrol.

• Norgestrel.

• Norgestimate.

• Warfarin.

Using Cedinir with any of the above medicines might increase the risk of certain side effects; however, using both drugs might be the best treatment option in some cases. If both medicines are administered together, the doctor might change the dose or how often the patient uses one or both.

Other Interactions:

Certain medicines must not be used at or around the time of eating or eating particular food types since interactions might be seen. The use of alcohol or tobacco with certain medications might cause some interactions. The patient should discuss with the healthcare professional the diet, alcohol, and tobacco consumption before starting this medication.

Specific Considerations:

• Patients With Renal Insufficiency: Cefdinir pharmacokinetics were documented in 21 adult subjects with different degrees of renal function. The reduction in Cefdinir elimination rate, renal clearance, and apparent oral clearance (CL/F) is proportional to the reduction in creatinine clearance (CrCl). Further, it was observed that plasma Cefdinir concentrations were higher and stayed for longer in subjects with renal impairment than in those without renal impairment.

• Hemodialysis: Cefdinir pharmacokinetics were studied in eight adults undergoing hemodialysis. Dialysis removed 63 % of Cefdinir from the body. Dosage adjustment is advised in such a patient population.

• Hepatic Disease: Cefdinir is renally eliminated and not significantly metabolized; studies in patients with hepatic impairment were not conducted. It is expected that dose adjustment is optional in this population.

• Geriatric Patients: The age-related effect on Cefdinir pharmacokinetics was evaluated in 32 subjects aged 19 to 91 after administration of a single 300 mg dose. Systemic exposure to Cefdinir was significantly increased in older subjects, with an AUC of 86 % and a Cmax of 44 %. This increase was due to a decrease in Cefdinir clearance. The apparent volume of distribution was also decreased; thus, no appreciable alterations in elimination t 1/2 were observed. Since Cefdinir clearance is more closely related to alterations in renal function than age, elderly patients do not need dosage adjustments unless they have significantly compromised renal function (creatinine clearance less than 30 mL/min).

• Gender and Race: The results of a pharmacokinetics meta-analysis documented no significant impact associated with gender or race on Cefdinir pharmacokinetics.