Atovaquone And Proguanil Hydrochloride

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Uses

1.1 Prevention of Malaria

Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.

1.2 Treatment of Malaria

Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.

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Other Information

Atovaquone and proguanil hydrochloride tablets (Adult Strength), for oral administration.are a fixed-dose combination of the antimalarial agents atovaquone USP and proguanil hydrochloride USP.

The chemical name of atovaquone USP is trans-2-[4-(4-chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione. Atovaquone USP is a yellow crystalline solid that is freely soluble in N-methyl-2-pyrrolidone and in tetrahydrofuran; soluble in chloroform; sparingly soluble in acetone and dimethyl sulfoxide; slightly soluble in octanol, ethyl acetate, polyethylene glycol 200; very slightly soluble in 0.1N sodium hydroxide; insoluble in water. It has a molecular weight of 366.84 and the molecular formula C 22H 19ClO 3. The compound has the following structural formula:

The chemical name of proguanil hydrochloride USP is 1-(4-chlorophenyl)-5-isopropyl-biguanide hydrochloride. Proguanil hydrochloride USP is a white crystalline powder slightly soluble in water, sparingly soluble in alcohol, practically insoluble in methylene chloride. It has a molecular weight of 290.22 and the molecular formula C 11H 16ClN 5•HCl. The compound has the following structural formula:

Each atovaquone and proguanil hydrochloride tablet contains 250 mg of atovaquone USP and 100 mg of proguanil hydrochloride USP. The inactive ingredients in the tablet are colloidal silicon dioxide, ferric oxide red, hypromellose 2910, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol 400, polyethylene glycol 8000, povidone K30, sodium starch glycolate and titanium dioxide.

Sources

Atovaquone And Proguanil Hydrochloride Manufacturers

Blenheim Pharmacal, Inc.

Atovaquone And Proguanil Hydrochloride | Blenheim Pharmacal, Inc.

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
2.1 Prevention of Malaria
Start prophylactic treatment with atovaquone and proguanil hydrochloride tablets 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.
Adults: One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
2.2 Treatment of Acute Malaria
Adults: Four atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive day.
2.3 Renal Impairment
Do not use atovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [See Contraindications (4.2)]. Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3 day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology ( 12.3).

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Rebel Distributors Corp

Atovaquone And Proguanil Hydrochloride | Rebel Distributors Corp

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Aidarex Pharmaceuticals Llc

Atovaquone And Proguanil Hydrochloride | Aidarex Pharmaceuticals Llc

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Physicians Total Care, Inc.

Atovaquone And Proguanil Hydrochloride | Physicians Total Care, Inc.

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Clinical Solutions

Atovaquone And Proguanil Hydrochloride | Clinical Solutions

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Pd-rx Pharmaceuticals, Inc.

Atovaquone And Proguanil Hydrochloride | Pd-rx Pharmaceuticals, Inc.

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Dispensing Solutions, Inc.

Atovaquone And Proguanil Hydrochloride | Dispensing Solutions, Inc.

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Clinical Solutions Wholesale

Atovaquone And Proguanil Hydrochloride | Clinical Solutions Wholesale

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
Prevention of Malaria:
Prophylactic treatment with atovaquone and proguanil hydrochloride should be started 1 or 2 days before entering a malaria-endemic area and continued daily during the stay and for 7 days after return.
Adults:
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Treatment of Acute Malaria: Adults:
Four Atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single dose daily for 3 consecutive days.
Patients with Renal Impairment:
Atovaquone and proguanil hydrochloride tablet should not be used for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min). Atovaquone and proguanil hydrochloride tablet may be used with caution for the treatment of malaria in patients with severe renal impairment (creatinine clearance <30 mL/min), only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment). No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) and moderate (creatinine clearance 30 to 50 mL/min) renal impairment (see CLINICAL PHARMACOLOGY: Special Populations).
Patients with Hepatic Impairment:
No dosage adjustments are needed in patients with mild to moderate hepatic impairment. No studies have been conducted in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY: Special Populations: Hepatic Impairment).

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Glenmark Generics Inc., Usa

Atovaquone And Proguanil Hydrochloride | American Health Packaging

Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].
2.1 Short-Term Treatment of Active Duodenal Ulcer
The recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence
Triple Therapy (omeprazole/clarithromycin/amoxicillin) — The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (omeprazole/clarithromycin) — The recommended adult oral regimen is omeprazole delayed-release capsuels 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.
2.3 Gastric Ulcer
The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.
2.4 Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
2.5 Maintenance of Healing of Erosive Esophagitis
The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [See Clinical Studies (14.4)].
2.6 Pathological Hypersecretory Conditions
The dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
2.7 Pediatric Patients
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
Patient Weight
Omeprazole Daily Dose
10 < 20 kg
10 mg
≥ 20 kg
20 mg
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].
2.8 Alternative Administration Options
Omeprazole is available as a delayed-release capsule.
For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.

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Mylan Pharmaceuticals Inc.

Atovaquone And Proguanil Hydrochloride | Mylan Pharmaceuticals Inc.

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within one hour after dosing, a repeat dose should be taken.
Atovaquone and proguanil hydrochloride tablets may be crushed and mixed with condensed milk just prior to administration to patients who may have difficulty swallowing tablets.
2.1Prevention of Malaria
Start prophylactic treatment with atovaquone and proguanil hydrochloride tablets 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.
Adults
One atovaquone and proguanil hydrochloride tablet (adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
Pediatric Patients
The dosage for prevention of malaria in pediatric patients is based upon body weight (Table 1).
Table 1. Dosage for Prevention of Malaria in Pediatric Patients
Weight
(kg)
Atovaquone/
Proguanil HCl
Total Daily Dose
Dosage Regimen
11 to 20
62.5 mg/25 mg
One atovaquone and proguanil hydrochloride pediatric tablet daily
21 to 30
125 mg/50 mg
Two atovaquone and proguanil hydrochloride pediatric tablets as a single daily dose
31 to 40
187.5 mg/75 mg
Three atovaquone and proguanil hydrochloride pediatric tablets as a single daily dose
> 40
250 mg/100 mg
One atovaquone and proguanil hydrochloride tablet (adult strength) as a single daily dose
2.2Treatment of Acute Malaria Adults
Four atovaquone and proguanil hydrochloride tablets (adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive days.
Pediatric Patients
The dosage for treatment of acute malaria in pediatric patients is based upon body weight (Table 2).
Table 2. Dosage for Treatment of Acute Malaria in Pediatric Patients
Weight (kg)
Atovaquone/
Proguanil HCl
Total Daily Dose
Dosage Regimen
5 to 8
125 mg/50 mg
Two atovaquone and proguanil hydrochloride pediatric tablets daily for 3 consecutive days
9 to 10
187.5 mg/75 mg
Three atovaquone and proguanil hydrochloride pediatric tablets daily for 3 consecutive days
11 to 20
250 mg/100 mg
One atovaquone and proguanil hydrochloride tablet (adult strength) daily for 3 consecutive days
21 to 30
500 mg/200 mg
Two atovaquone and proguanil hydrochloride tablets (adult strength) as a single daily dose for 3 consecutive days
31 to 40
750 mg/300 mg
Three atovaquone and proguanil hydrochloride tablets (adult strength) as a single daily dose for 3 consecutive days
> 40
1 g/400 mg
Four atovaquone and proguanil hydrochloride tablets (adult strength) as a single daily dose for 3 consecutive days
2.3Renal Impairment
Do not use atovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance < 30 mL/min) [see Contraindications (4.2)]. Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3-day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology (12.3).]

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Bluepoint Laboratories

Atovaquone And Proguanil Hydrochloride | Bluepoint Laboratories

The daily dose should be taken at the same time each day with food or a milky drink. In the event of vomiting within 1 hour after dosing, a repeat dose should be taken.
2.1 Prevention of Malaria
Start prophylactic treatment withatovaquone and proguanil hydrochloride tablets 1 or 2 days before entering a malaria-endemic area and continue daily during the stay and for 7 days after return.
Adults: One atovaquone and proguanil hydrochloride tablet(adult strength = 250 mg atovaquone/100 mg proguanil hydrochloride) per day.
2.2 Treatment of Acute Malaria
Adults: Fouratovaquone and proguanil hydrochloride tablets(adult strength; total daily dose 1 g atovaquone/400 mg proguanil hydrochloride) as a single daily dose for 3 consecutive day.
2.3 Renal Impairment
Do not useatovaquone and proguanil hydrochloride tablets for malaria prophylaxis in patients with severe renal impairment (creatinine clearance <30 mL/min) [See Contraindications (4.2)]. Use with caution for the treatment of malaria in patients with severe renal impairment, only if the benefits of the 3 day treatment regimen outweigh the potential risks associated with increased drug exposure. No dosage adjustments are needed in patients with mild (creatinine clearance 50 to 80 mL/min) or moderate (creatinine clearance 30 to 50 mL/min) renal impairment. [See Clinical Pharmacology (12.3).

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